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Last update 23 Jan 2025

Sertraline Hydrochloride

Last update 23 Jan 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummarySertraline, a pharmaceutical solution commonly utilized to alleviate the symptoms of depression, anxiety disorders, and obsessive-compulsive disorder (OCD) among adults and children, is a selective serotonin reuptake inhibitor (SSRI) drug that impacts the delicate interplay of neurotransmitters in the brain. With a mechanism of action predicated upon the facilitation of serotonin, a neurotransmitter in the brain that regulates mood, this medication is typically taken once per day, either with or without food, and may require multiple weeks of consistent usage before its intended effects can be fully realized. Nevertheless, as with all pharmacological interventions, sertraline carries with it a list of potential side effects, ranging from nausea to insomnia to sexual dysfunction, thereby underscoring the importance of working in concert with a qualified healthcare provider to ascertain whether this medication is a safe and effective treatment option for one's unique condition.

Drug Type

Small molecule drug

Synonyms

Aremis, Besitran, Gladem

+ [19]

Target

SERT

Mechanism

Serotonin reuptake inhibitors

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Phobia, SocialPremenstrual Dysphoric DisorderDepressive Disorder, Major+ [5]

Inactive Indication-

Originator Organization

Pfizer Inc.

Active Organization

Viatris Specialty LLC

Pfizer Inc.

Almatica Pharma LLC

+ [3]

Inactive Organization

Viatris, Inc.Mylan Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1990),

Anxiety DisordersDepressive DisorderObsessive-Compulsive Disorder

Regulation-

Structure/Sequence

Molecular FormulaC17H18Cl3N

InChIKeyBLFQGGGGFNSJKA-XHXSRVRCSA-N

CAS Registry79559-97-0

291

Clinical Trials associated with Sertraline Hydrochloride

NCT06408246

/ Not yet recruitingPhase 2IIT

ACE-D: Accelerating Cognition-guided Signatures to Enhance Translation in Depression: Clinical Trial

The purpose of this study is to understand how a psychotropic medication called guanfacine affects brain network functioning in humans, and how this function interacts with cognitive impairments in people experiencing depressive symptoms.

Start Date01 Feb 2026

Sponsor / Collaborator

Stanford University

NCT06704594

/ Not yet recruitingPhase 4IIT

Allopregnanolone and Dynamic GABA-A Receptor Plasticity in Selective Serotonin Reuptake Inhibitor Responsive Premenstrual Dysphoric Disorder

The goals of this multi-site randomized placebo controlled trial (RCT) are to characterize three aspects of neuroactive steroid (NAS) dysfunction across the luteal phase of the menstrual cycle in premenstrual dysphoric disorder (PMDD) compared with healthy controls, and to assess how Selective serotonin reuptake inhibitors (SSRI) treatment in PMDD impacts: 1) GABAergic NAS fluctuations, particularly positive allosteric modulators (PAMs: allopregnanolone (ALLO), pregnanolone) and negative allosteric modulators (NAMs: isoallopregnanolone, epipregnanolone) of the GABAA receptor (GABAAR), 2) GABAAR subunit expression, and 3) neurosteroidogenic enzyme expression.

Start Date01 Feb 2025

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT05973786

/ RecruitingPhase 3IIT

A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Bipolar disorders affect approximately 4.5 million people across the European Union (EU) and are associated with high annual healthcare and societal costs. Bipolar disorder I and II represent disorders that cause extreme fluctuation in a person's mood, energy, and ability to function, in which symptoms of (hypo)mania and depression alternate. The depressive episodes of bipolar disorders are often referred to as bipolar depression (BD). In other words: it is a phase/state of the disorder. For many patients with BD, the depressive polarity is often more pervasive and more debilitating than manic states, with estimates that depressed mood accounts for up to two-thirds of the time spent unwell, even with treatment. The burden of not received an effective treatment for BD is high: more severe psychopathology, higher rates of unemployment, more hospitalisations, lower quality of life, lower cognitive functioning, risk of suicide, comorbidities and poorer social and occupational functioning and thus more carer burden. For BD, the treatment guidelines are very heterogeneous, amongst other reasons because the disease is heterogeneous and treatments should be tailored to the patients. There is no clear treatment algorithm and it cannot yet be predicted which treatment will be effective. Especially the place of adjunctive antidepressants is under debate. Usually, for psychiatric disorders (including bipolar disorder), a patient is considered to be treatment-resistant is two medicinal treatments have been tried (in sufficient duration and dosage) without sufficient success. For BD, there is no consensus on when to consider a patient as treatment-resistant, but the most common definition is after one prior treatment failure. This raises the research question whether adjunctive antidepressants to treat BD should be introduced earlier in the treatment. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

Start Date31 Jan 2025

Sponsor / Collaborator

University Medical Center of Utrecht

[+1]

100 Clinical Results associated with Sertraline Hydrochloride

100 Translational Medicine associated with Sertraline Hydrochloride

100 Patents (Medical) associated with Sertraline Hydrochloride

5,861

Literatures (Medical) associated with Sertraline Hydrochloride

01 Mar 2025·SLEEP MEDICINE

Trends in anti-insomnia medication utilization among pediatric patients in nine cities in China: A real-world study (2016–2023)

Article

Author: Xing, Lipeng ; Li, Ziheng ; Liu, Maochang ; Jiang, Hailun

OBJECTIVE:

To investigate prescription patterns of insomnia medications among Chinese children, assess the current status of drug treatment, and offer data to support the guidance of clinical prescribing practices.

METHODS:

This study analyzed pediatric prescriptions for insomnia medications from the China Hospital Prescription Analysis Cooperation Project database across nine cities between 2016 and 2023. The analysis focused on demographic characteristics, prescription trends, and frequency of medication use among pediatric insomnia patients. Patterns of combination therapy were also examined.

RESULTS:

The number of children receiving insomnia medications increased substantially from 228 in 2016 to 1166 in 2023, representing an approximate 409 % increase. A growing proportion of patients were aged 12-14 years, with female patients outnumbering males by a ratio of 1.50: 1. There was an increased representation of patients from psychiatry and neurology departments. Regarding medication choices, benzodiazepines (BZDs) remained the most commonly prescribed class, though their use showed a declining trend. Similarly, non-benzodiazepine receptor agonists (nBZRAs) demonstrated a downward trend (P > 0.05), while antidepressant prescriptions significantly increased (P < 0.05). The most commonly prescribed medications within each class were alprazolam, zolpidem, trazodone, sertraline, and quetiapine. A significant proportion of patients (37.25 %) received combination therapy, with benzodiazepine receptor agonists (BZRAs) plus antidepressants being the most common combination.

CONCLUSIONS:

The utilization of pharmacological interventions for pediatric insomnia in China has risen markedly in recent years. Despite growing concerns about adverse effects, BZDs continue to be the primary therapeutic choice. The increasing prevalence of combination therapy suggests a trend toward more individualized treatment approaches. These findings underscore the importance of careful monitoring and rational prescribing practices in pediatric insomnia management.

01 Mar 2025·JOURNAL OF AFFECTIVE DISORDERS

Effect of continuous esketamine infusion on brain white matter microstructure in patients with major depression: A diffusion tensor imaging study

Article

Author: Liu, Xiang ; Peng, Dechang ; Wan, Xin ; Li, Jiangping ; Deng, Yingke ; Wu, Guojiang ; Wei, Zhipeng ; Liu, Yumeng ; Li, Lifeng ; Li, Haijun

INTRODUCTION:

Esketamine has demonstrated acute antidepressant effects in patients with major depressive disorder (MDD). This study investigated whether these effects associate with reversible white matter fiber integrity recovery using diffusion imaging.

METHOD:

Twenty patients with MDD and 20 healthy controls received 2-week esketamine treatment. Patients received 0.25 mg/kg intravenous esketamine. Emotional and cognitive recovery were assessed. Diffusion tensor imaging and tract-based spatial statistics evaluated white matter fiber integrity pre/post-treatment. Correlation analyses examined associations between white matter changes and clinical scales.

RESULTS:

Compared to controls, patients with MDD exhibited decreased fractional anisotropy (FA) values of cerebral white matter fibers involving the association fibers, the commissural fibers and projection fibers. Esketamine effectively reduced depression, anxiety, and suicidal ideation scores while improving cognitive function. However, no reversible recovery of compromised white matter integrity was observed after 2 weeks of esketamine treatment. FA reductions in projection fibers correlated with anxiety and suicidal ideation severity.

LIMITATIONS:

Concurrent sertraline use and lack of placebo control limited our ability to isolate esketamine's effects. The wide age range may have introduced response variability. We used minimal effective dosages based on previous research. The small sample size limited statistical power. Larger, more controlled studies are needed to validate these preliminary findings.

DISCUSSION:

This study enhances MDD neuropathological understanding, with widespread white matter impairment and associations between projection fibers and symptom severity. While producing significant antidepressant effects, short-term esketamine did not recover compromised white matter microstructure.

01 Feb 2025·ARCHIVES OF GERONTOLOGY AND GERIATRICS

The molecular mechanisms of steroid hormone effects on cognitive function

Review

Author: Kim, Woong-Ki ; Vu, Giang Huong ; Nguyen, Hai Duc

OBJECTIVE:

There is a lack of information on the molecular mechanisms by which steroid hormones (testosterone, estrogen, and progesterone) regulate cognitive impairment. Thus, we aimed to identify the protective effects of steroid hormones on cognitive function.

METHODS:

We analyzed the literature on the molecular mechanisms, biological activities, physicochemical properties, and pharmacokinetics of steroid hormones.

RESULTS:

Steroid hormones can protect against cognitive impairment by regulating key genes (INS, TNF, STAT3, ESR1). Specific microRNAs, namely hsa-miR-335-5p, hsa-miR-16-5p, and hsa-miR-26b-5p, along with transcription factors NFKB1, PPARG, NR3C1, GATA2, EGR1, ATF3, and CEBPA, play a significant role in this protective mechanism. The involvement in cognitive processes, regulation of phosphorylation, neuronal apoptosis, and signaling pathways related to Alzheimer's disease significantly influence the protein-protein interaction network underlying these effects. Additionally, steroid hormones exhibit anti-hypercholesterolemic properties, anti-inflammatory activity, antitoxic properties, and function as inhibitors of acetylcholine neuromuscular transmission. They also hold promise as therapeutic agents for the treatment of dementia. Promising therapeutic interventions for cognitive impairment include the use of miRNA sponges targeting hsa-miR-16-5p, along with the administration of capsaicin, minocycline, dopamine, sertraline, and minaprine. The gut microbiota species Lactobacillus amylovorus, Paraprevotella clara, Libanicoccus massiliensis, Prevotella oris, Turicibacter sanguinis, and Dubosiella newyorkensis were identified as significant contributors to cognitive impairment and altered levels of steroid hormones.

CONCLUSION:

Steroid hormones are promising compounds for improving cognitive function. Further research is needed to validate these findings through focused investigations into apoptosis, regulation of neuronal cell death, miRNA sponges, interactions with gut microbiota, and the potential efficacy of pharmaceutical agents.

News (Medical) associated with Sertraline Hydrochloride

10 Jan 2025

·www.businesswire.com

Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)

PRINCETON, N.J. & TOKYO--( BUSINESS WIRE )--Otsuka America Pharmaceutical, Inc., (OAPI) and Otsuka Pharmaceutical, Co., Ltd. (Otsuka) announce that the U.S. Food and Drug Administration (FDA) plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to seek input on issues related to the Supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The FDA’s decision to host a PDAC meeting does not reflect a final decision on the approvability. A final date for the meeting has yet to be set by the FDA, but it is currently anticipated to occur during the first half of 2025. This decision means that the Prescription Drug User Fee Act (PDUFA) target action date, originally planned for February 8, 2025, will be delayed. About Post-Traumatic Stress Disorder PTSD is one of the most common mental health disorders in the United States, with approximately five percent of the population affected during a given year i, ii, iii, iv . Most patients (>80%) with PTSD in the United States are in the civilian population v, vi . It may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience an event that is emotionally or physically harmful or life-threatening and which may affect mental, physical, social, and/or spiritual well-being. Examples of traumatic events include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, intimate partner violence and bullying vii, viii . Symptoms of PTSD are generally grouped into four symptom clusters: intrusion (re-experiencing), avoidance, negative cognitions and mood, and marked alterations in arousal and reactivity ix . Individual symptom type and intensity can fluctuate over time and between individuals. The average time from index trauma to symptom presentation is typically 2.2 years, and the average time from index trauma to PTSD diagnosis is typically 8.7 years. To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, and they must be severe enough to interfere with aspects of daily life, such as relationships or work. Symptoms also must not be due to medications, substance use, or another medical condition. Guideline-recommended first-line treatment includes psychotherapy (e.g., cognitive behavioral therapy) and first line pharmacotherapy options include certain antidepressants x . About brexpiprazole Brexpiprazole was approved in the U.S. by FDA in 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder (MDD) and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease, in May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively, and for agitation associated with dementia due to Alzheimer's disease in 2024. It was approved by the European Medicines Agency in 2018 for the treatment of schizophrenia and the Ministry of Health, Labour and Welfare in Japan for the treatment of schizophrenia and MDD in 2018 and 2023, respectively. In 2024, Japan’s Ministry of Health, Labour and Welfare also approved brexpiprazole for the treatment of excessive motor activity or physically/verbally aggressive behavior due to rapid changes in mood, irritability, and/or outbursts associated with dementia due to Alzheimer’s disease. Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor binding affinity to norepinephrine, serotonin and dopamine receptors. It is an antagonist at norepinephrine α1B and α2C receptors and serotonin 5-HT 2A receptors, as well as a partial agonist at serotonin 5-HT 1A and dopamine D2 receptors xi, xii . INDICATIONS and IMPORTANT SAFETY INFORMATION for REXULTI ® (brexpiprazole) INDICATIONS: REXULTI is a prescription medicine used: along with antidepressant medicines to treat major depressive disorder (MDD) in adults to treat schizophrenia in adults and children ages 13 years and older to treat agitation that may happen with dementia due to Alzheimer’s disease REXULTI should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease. It is not known if REXULTI is safe and effective in children with MDD. It is not known if REXULTI is safe and effective in children under 13 years of age with schizophrenia. IMPORTANT SAFETY INFORMATION: Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer’s disease. Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase suicidal thoughts and actions in pediatric patients and young adult patients, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. All patients on antidepressants and their families or caregivers should closely watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. Report any change in these symptoms immediately to the doctor. Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. REXULTI may cause serious side effects, including: Cerebrovascular problems, including stroke, in elderly people with dementia-related psychosis that can lead to death. Neuroleptic malignant syndrome (NMS) is a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS: high fever; changes in your pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; increased sweating Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI. Problems with your metabolism such as: high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start REXULTI and then regularly during long term treatment with REXULTI. Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with REXULTI: feel very thirsty feel very hungry feel sick to your stomach need to urinate more than usual feel weak or tired feel confused, or your breath smells fruity increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start REXULTI, and then periodically during treatment with REXULTI. weight gain. You and your healthcare provider should check your weight before you start and often during treatment with REXULTI. Unusual and uncontrollable (compulsive) urges. Some people taking REXULTI have had strong unusual urges, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having new or unusual strong urges or behaviors, talk to your healthcare provider. Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with REXULTI. Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded or pass out (faint) when you rise too quickly from a sitting or lying position. Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries. Seizures (convulsions). Problems controlling your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with REXULTI. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. Difficulty swallowing that can cause food or liquid to get into your lungs. Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy. Before taking REXULTI, tell your healthcare provider about all of your medical conditions, including if you: have or have had heart problems or a stroke have or have had low or high blood pressure have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar. have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol have or have had seizures (convulsions) have or have had kidney or liver problems have or have had a low white blood cell count are pregnant or plan to become pregnant. REXULTI may harm your unborn baby. Taking REXULTI during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take REXULTI during pregnancy. Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with REXULTI. There is a pregnancy exposure registry for women who are exposed to REXULTI during pregnancy. If you become pregnant during treatment with REXULTI, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . are breastfeeding or plan to breastfeed. It is not known if REXULTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REXULTI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. REXULTI and other medicines may affect each other causing possible serious side effects. REXULTI may affect the way other medicines work, and other medicines may affect how REXULTI works. Your healthcare provider can tell you if it is safe to take REXULTI with your other medicines. Do not start or stop any medicines during treatment with REXULTI without first talking to your healthcare provider. The most common side effects of REXULTI include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of REXULTI (brexpiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ). Please read FULL PRESCRIBING INFORMATION , including BOXED WARNING , and MEDICATION GUIDE for REXULTI . About Otsuka Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: Otsuka–people creating new products for better health worldwide. Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. In pharmaceuticals, Otsuka is a leader in the challenging areas of mental, renal, and cardiovascular health and has additional research programs in oncology and on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does. Otsuka established a presence in the U.S. in 1973 and today its U.S. affiliates include Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). These two companies’ 2,250 employees in the U.S. develop and commercialize medicines in the areas of mental health and nephrology, using cutting-edge technology to address unmet healthcare needs. OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Co., Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023. All Otsuka stories start by taking the road less traveled. Learn more about Otsuka in the U.S. at www.otsuka-us.com and connect with us on LinkedIn and Twitter at @OtsukaUS . Otsuka Pharmaceutical Co., Ltd.’s global website is accessible at https://www.otsuka.co.jp/en/ . ______________________ i Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012;21(3):169-184. ii Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [published correction appears in Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9. iii Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Clin Med. 2016;5(11):105. iv U.S. Department of Veterans Affairs. How Common Is PTSD in Adults? Last updated: Feb. 3, 2023. Last accessed: April 30, 2024. Available at: https://www.ptsd.va.gov/understand/common/common_adults.asp v Davis LL, Schein J, Cloutier M, et al. The Economic Burden of Posttraumatic Stress Disorder in the United States From a Societal Perspective. J Clin Psychiatry. 2022;83(3):21m14116. vi Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication [published correction appears in Arch Gen Psychiatry. 2005 Jul;62(7):768. Merikangas, Kathleen R [added]]. Arch Gen Psychiatry. 2005;62(6):593-602. vii American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013 viii American Psychiatric Association. What is Posttraumatic Stress Disorder (PTSD)? Last updated: November 2022. Last accessed: August 28, 2024. Available at: https://www.psychiatry.org/patients-families/ptsd/what-is-ptsd . ix Wang PS, Berglund P, Olfson M, Pincus HA, Wells KB, Kessler RC. Failure and delay in initial treatment contact after first onset of mental disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62(6):603-613. x U.S. Department of Veterans Affairs. VA/DoD Clinical Practice Guidelines. Management of Posttraumatic Stress Disorder and Acute Stress Disorder. Provider Summary 2023. Version 4.0. www.healthquality.va.gov/guidelines/MH/ptsd/VA-DoD-CPG-PTSD-Provider-Summary.pdf xi REXULTI® (brexpiprazole). Prescribing Information. FDA. xii Maeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharmacol Exp Ther. 2014;350(3):589-604.

Drug Approval

19 Dec 2024

·www.otsuka.co.jp

JAMA Psychiatry Publishes Results of Otsuka and Lundbeck's Phase 3 Trial of Brexpiprazole in Combination with Sertraline in Treatment of Post-Traumatic Stress Disorder (PTSD) in Adults

RSS Brexpiprazole in combination with sertraline demonstrated a statistically significant reduction in overall PTSD symptoms compared to sertraline plus placebo, as measured by change in CAPS-5 total score from Week 1 to Week 101 The safety profile of brexpiprazole in combination with sertraline was consistent with that of brexpiprazole in approved indications1 Otsuka and Lundbeck submitted an sNDA for brexpiprazole in combination with sertraline for the treatment of adults with PTSD in April 2024. The sNDA is currently under FDA review with a PDUFA target date of February 8, 2025 PTSD is a highly prevalent, trauma-based neuropsychiatric disorder that impacts approximately 13 million U.S. adults in a given year, and nearly 6 in 100 people will be diagnosed with PTSD in their lifetime2-6 Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that its US subsidiary Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Lundbeck Pharmaceuticals LLC (Lundbeck) today announced that the full results of a Phase 3 trial of brexpiprazole in combination with sertraline for the treatment of PTSD in adults have been published in JAMA Psychiatry. The results showed that in adults with PTSD, treatment with brexpiprazole in combination with sertraline resulted in statistically significant greater improvement of PTSD symptoms vs treatment with sertraline plus placebo, as measured by change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from Week 1 to Week 10.1 "About 6% of the United States population will have PTSD at some point in their lives, but around only half will seek treatment," said Lori Davis, M.D., clinical professor of psychiatry in the Department of Psychiatry and Behavioral Neurobiology, University of Alabama School of Medicine, who served as lead author on the JAMA Psychiatry manuscript. "The Phase 3 results are an important and encouraging step forward in the hopes of providing PTSD patients with a new therapeutic option in the future." About the Phase 3 Trial The Phase 3 randomized, double-blind, active-controlled, parallel-arm trial (NCT04124614) evaluated the efficacy, safety, and tolerability of brexpiprazole in combination with sertraline for the treatment of PTSD. The trial included 416 adult outpatients who were randomized to receive either brexpiprazole (2-3 mg/day) with sertraline (150 mg/day) or sertraline (150 mg/day) with a placebo. The primary endpoint was the change in CAPS-5 total score from randomization (Week 1) to Week 10. Patients receiving brexpiprazole with sertraline showed a statistically significant greater improvement in CAPS-5 total score (-19.2) compared to those receiving sertraline with placebo (-13.6), with a least squares (LS) mean difference of -5.59 (95% CI: -8.79 to -2.38; P<.001). Additionally, both secondary endpoints, the change in the Clinical Global Impression- Severity of Illness score (CGI-S) randomization (week 1) to week 10 and the change in the Brief Inventory of Psychosocial Function (B-IPF) from baseline (Day 0) to week 12, were also met.1 "The clinical trial results demonstrate the potential of brexpiprazole in combination with sertraline as a treatment option for patients with PTSD, a condition that affects millions within the United States," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "The combination of brexpiprazole and sertraline demonstrated meaningful improvements in PTSD symptoms." The safety profile of brexpiprazole in combination with sertraline was consistent with that of brexpiprazole in approved indications. The proportion of treated participants who discontinued due to adverse events was 3.9% (8/205) for brexpiprazole + sertraline and 10.2% (20/196) for sertraline + placebo.1 The adverse events occurring in >=5% for brexpiprazole in combination with sertraline (n=205) compared to sertraline and placebo (n=196) were nausea (12.2% vs 11.7%), fatigue (6.8% vs 4.1%), weight increase (5.9% vs 1.5%), and somnolence (5.4% vs. 2.6%), respectively.1 "The outcome of this trial provides us with an opportunity to help patients with PTSD," said Johan Luthman, executive vice president and head of Research & Development at Lundbeck. "With these promising results, we are committed to working closely with the FDA to help bring brexpiprazole in combination with sertraline to the healthcare professionals serving the PTSD patient community." About CAPS-5 The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a structured interview designed to assess PTSD diagnostic status and symptom severity as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). The CAPS-5 consists of 30 items, with a higher score indicating a worse outcome.1 The CAPS-5 includes 20 DSM-5 PTSD-symptom items that are each scored from 0 (absent) to 4 (extreme/incapacitating). The total score is calculated by summing the 20 items, and symptom cluster scores by summing specific items: Intrusion (items 1-5); Avoidance (items 6-7); Negative cognitions and mood (items 8-14); and Arousal and reactivity (items 15-20).1 The CGI-S is a 7-point categorical scale, originally developed for mental disorders, but now applied to various illnesses, that requires a clinician to rate the severity of a patient's illness at the time of assessment, relative to the clinician's experience with patients who have the same diagnosis.7 The B-IPF is an abridged, 7-item version of the Inventory of Psychosocial Functioning (IPF) which assesses PTSD-related functional impairment in the prior 30 days across the same domains that are assessed by the 80-item version of the IPF; each item on the B-IPF corresponds to one IPF functional domain.8 About Post-Traumatic Stress Disorder PTSD is one of the most common mental health disorders in the United States, with approximately five percent of the population affected during a given year.2, 4, 9, 10 Most patients (>80%) with PTSD in the United States are in the civilian population.4, 11 It may occur in people who have experienced or witnessed a traumatic event, series of events or set of circumstances. An individual may experience an event that is emotionally or physically harmful or life-threatening which may affect mental, physical, social, and/or spiritual well-being. Examples of traumatic events include physical/sexual assault, natural disasters, serious accidents, terrorist acts, war/combat, historical trauma, intimate partner violence and bullying.12, 13 Symptoms of PTSD are generally grouped into four symptom clusters: intrusion (re-experiencing), persistent avoidance of stimuli, negative alterations in cognitions and mood, and marked alterations in arousal and reactivity. Individual symptom type and intensity can fluctuate over time and between individuals. To meet the criteria for PTSD diagnosis, symptoms must last longer than one month, and they must be severe enough to interfere with aspects of daily life, such as relationships or work. Symptoms also must not be due to medications, substance use, or another medical condition.10, 12 The average time from index trauma to symptom presentation is 2.2 years, and the average time from index trauma to PTSD diagnosis is 8.7 years.14 About Brexpiprazole Brexpiprazole was approved in the U.S. by the FDA in 2015, as an adjunctive therapy to antidepressants in adults with major depressive disorder (MDD) and as a treatment for schizophrenia in adults. Most recently, brexpiprazole was approved in the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease, in May 2023. Brexpiprazole was also approved by Health Canada for schizophrenia and adjunctive treatment of MDD in 2017 and 2019, respectively, and for agitation associated with dementia due to Alzheimer's disease in 2024. It was approved by the European Medicines Agency in 2018 for the treatment of schizophrenia and the Ministry of Health, Labour and Welfare in Japan for the treatment of schizophrenia and MDD in 2018 and 2023, respectively. Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism of action of brexpiprazole is unknown. Brexpiprazole has high receptor binding affinity to norepinephrine, serotonin and dopamine receptors. It is an antagonist at norepinephrine α1B and α2C receptors and serotonin 5-HT2A receptors, as well as a partial agonist at serotonin 5-HT1A and dopamine D2 receptors.15, 16 References 1. Davis LL, Behl S, Lee D, et al. Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder. JAMA Psychiatry. Published online December 18, 2024. doi:10.1001/jamapsychiatry.2024.3996 2. U.S. Department of Veterans Affairs. How Common Is PTSD in Adults? Accessed September 2024. www.ptsd.va.gov/understand/common/common_adults.asp. 3. US Census Bureau. (2022). National Population by Characteristics: 2020-2022. Retrieved from www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html. 4. Lehavot K, Katon JG, Chen JA, Fortney JC, Simpson TL. Post-traumatic Stress Disorder by Gender and Veteran Status [published correction appears in Am J Prev Med. 2019 Oct;57(4):573]. Am J Prev Med. 2018;54(1):e1-e9. 5. Goldstein RB, Smith SM, Chou SP, et al. The epidemiology of DSM-5 posttraumatic stress disorder in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions-III. Soc Psychiatry Psychiatr Epidemiol. 2016;51(8):1137-1148. 6. Schein J, Houle C, Urganus A, et al. Prevalence of post-traumatic stress disorder in the United States: a systematic literature review. Curr Med Res Opin. 2021;37(12):2151-2161. 7. Busner J, Targum SD. The clinical global impressions scale: applying a research tool in clinical practice. Psychiatry (Edgmont). 2007;4(7):28-37. 8. U.S. Department of Veterans Affairs. Inventory of Psychosocial Functioning (IPF). Accessed December 2024. https://www.ptsd.va.gov/professional/assessment/functioning-other/ipf_psychosocial_function.asp 9. Kessler RC, Petukhova M, Sampson NA, Zaslavsky AM, Wittchen H -U. Twelve-month and lifetime prevalence and lifetime morbid risk of anxiety and mood disorders in the United States. Int J Methods Psychiatr Res. 2012;21(3):169-184. 10. Lancaster CL, Teeters JB, Gros DF, Back SE. Posttraumatic Stress Disorder: Overview of Evidence-Based Assessment and Treatment. J Clin Med. 2016;5(11):105. 11. Davis LL, Schein J, Cloutier M, et al. The Economic Burden of Posttraumatic Stress Disorder in the United States From a Societal Perspective. J Clin Psychiatry. 2022;83(3):21m14116. 12. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, VA, American Psychiatric Association, 2013 13. American Psychiatric Association. What is Posttraumatic Stress Disorder (PTSD)? Last updated: November 2022. Last accessed: August 28, 2024. Available at: www.psychiatry.org/patients-families/ptsd/what-is-ptsd. 14. Davis LL, Urganus A, Gagnon-Sanschagrin P, et al. Patient journey of civilian adults diagnosed with posttraumatic stress disorder-A chart review study. Curr Med Res Opin. 2024;40(3):505-516. 15. Maeda K, Sugino H, Akazawa H, et al. Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator. J Pharmacol Exp Ther. 2014;350(3):589-604. 16. REXULTI® (brexpiprazole). Prescribing Information. FDA. Reference ID: 4911319. May 2024.

Clinical ResultPhase 3Drug Approval

23 Sep 2024

·www.drugs.com

Psilocybin Equals or Exceeds SSRI Antidepressants at Easing Depression

MONDAY, Sept. 23, 2024 -- Psilocybin, the active ingredient in magic mushrooms, appears to ease depression symptoms at least as well as one of the most commonly used antidepressants , a new clinical trial shows. Patients showed significant improvement in their depressive symptoms after taking either a single dose of psilocybin or a six-week course of the SSRI antidepressant escitalopram ( Lexapro ), researchers reported Sept. 21 in the journal Lancet eClinicalMedicine1. They also presented the findings at the European College of Neuropsychopharmacology’s annual meeting in Milan. However, patients given psilocybin also reported additional long-term benefits, including a greater sense of meaning in life and better psychological connectedness to others. “Both treatments led to comparable improvements in alleviating symptoms of depression at the six-week mark, such as sadness and negative emotions,” said lead researcher Tommaso Barba , a doctoral candidate with Imperial College London in the U.K. “However, this work shows that psilocybin outperformed escitalopram in several measures of well-being, meaning in life, work and social functioning,” Barba said in a journal news release. “These results appeared to be maintained over a six-month follow-up period.” SSRI antidepressants like Prozac, Paxil and Zoloft are one of the main types of drugs used to treat depression, researchers said. However, about a third of patients don’t respond to treatment. “SSRIs work well, but not for everyone. They are also associated with some side effects,” Barba said. “This work implies that psilocybin generally seems to offer a real alternative, and perhaps additional benefits, to people who are worried about taking conventional antidepressants.” For the clinical trial, researchers recruited 59 patients with severe depression and assigned 30 to undergo a single psilocybin therapy session. The other 29 were prescribed escitalopram for six weeks. Up to six months later, patients in both groups showed similar improvements in their depression symptoms, researchers said. But only psilocybin produced additional benefits regarding well-being and meaning in life, they added. “This is important because improving connectedness and having greater meaning in life can significantly enhance a person's quality of life and long-term mental health,” said senior researcher Dr. David Erritzoe , clinical director of the Center for Psychedelic Research at Imperial College London. “The study suggests that psilocybin therapy might be a more holistic treatment option for depression, addressing both the symptoms of depression and overall well-being,” Erritzoe added. “This could make a substantial difference in the overall happiness and daily activities of those suffering from depression, providing a more joined-up approach to mental health treatment.” However, Erritzoe cautioned that psilocybin is still an experimental drug that’s administered in highly controlled environments, so people shouldn’t try using magic mushrooms to self-medicate at home. “These precautions are not found in recreational psychedelic use, which is known for having unpredictable and potentially harmful effects, especially for vulnerable people struggling with mental health issues,” Erritzoe said. Johan Lundberg , an adjunct professor of psychiatry with the Karolinska Institute in Stockholm, Sweden, agreed with Erritzoe’s caution regarding psilocybin use. “For now, we don’t know if psilocybin will be approved for the treatment of major depression, but if so, it won’t be for everyone,” said Lundberg, who was not involved in the research. “Some future patients might prefer psychedelic treatment over SSRI, but some patients may be intimidated by the dramatic alterations in perception and confrontations with challenging emotions that psychedelic drugs promote.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Sertraline Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00825	Sertraline Hydrochloride	N06AB06	DB01104

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Phobia, Social	US	Viatris Specialty LLC	07 Feb 2003
Premenstrual Dysphoric Disorder	US	Viatris Specialty LLC	16 May 2002
Depressive Disorder, Major	US	Viatris Specialty LLC	30 Dec 1991
Panic Disorder	US	Viatris Specialty LLC	30 Dec 1991
Stress Disorders, Post-Traumatic	US	Viatris Specialty LLC	30 Dec 1991
Anxiety Disorders	-	Pfizer Inc.	01 Jan 1990
Depressive Disorder	-	Pfizer Inc.	01 Jan 1990
Obsessive-Compulsive Disorder	-	Pfizer Inc.	01 Jan 1990

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03033069 \| NCT04124614 \| NCT04174170 (331-201-00072, Biospace) Manual	Phase 2/3	Stress Disorders, Post-Traumatic	-	Brexpiprazole in combination with sertraline (331-201-061)	ubqwnziwdg(koebafiomz) = fptshugcdh fsgvwaaimk (wjgcckyjpx )	Positive	28 May 2024
				sertraline plus placebo (331-201-061)	ubqwnziwdg(koebafiomz) = nlxxryrusk fsgvwaaimk (wjgcckyjpx )
NCT01437189 (PD, CTgov)	Not Applicable	Depressive Disorder \| Parkinson Disease	35	Sertraline	kbepsuxaid(igyavccsdw) = lniidtnyko nlvizchckh (eypyfcjgme, netowhefzv - kewhtgqyon) View more	-	30 Jan 2024
NCT02777372 (CTgov)	Phase 4	Premenstrual Dysphoric Disorder	84	sertraline (Control)	ledsvabwfv(vklazypdbi) = seeldzenfo qosefdataq (hfptuokvnt, pllfrorjim - vvdoekfolc) View more	-	17 Nov 2022
				Sertraline (Sertraline)	ledsvabwfv(vklazypdbi) = paswgakctj qosefdataq (hfptuokvnt, jwsonwzgwd - nabmgelryy) View more
ENDO2021	Not Applicable	Calcium Metabolism Disorders	23	Sertraline 10 mg/kg/d	jebogmwasa(prnhgonilt) = vkqekbruqa aopgeduyag (dqtrnghqro ) View more	-	03 May 2021
				Vehicle (DMSO)	jebogmwasa(prnhgonilt) = wlgnzfclmj aopgeduyag (dqtrnghqro ) View more
NCT02185547 (Pubmed \| Eur J Clin Pharmacol)	Phase 4	-	17	Sertraline	ftrtjdbqwl(zriqboscdm) = gqeulojpqu msrcjqiebw (hmtryauzru )	-	22 Mar 2021
NCT02901249 (CTgov)	Phase 4	Depressive Disorder, Major	68	Nortriptyline+sertraline+Lithium	jkhcpnsskh(enecwpiure) = iutcdlayui rzdztbyvzp (onfzbrhhlg, vmnjgpgswl - mofkkyuiha) View more	-	14 Oct 2020
SLATAN STUDY (ERA2020)	Not Applicable	Dialysis hypotension diabetes	37	Sertraline 50 mg/day to 100 mg/day	nnnxnknbss(ypdcjwppjq) = vbflhjntab idlfaqspcb (zplamxokuf, 2.3)	Positive	06 Jun 2020
				Placebo	nnnxnknbss(ypdcjwppjq) = aqiikrwuxx idlfaqspcb (zplamxokuf, 2.7)
NCT01802385 (ASTRO-CM, CTgov)	Phase 3	Meningitis, Cryptococcal	460	fluconazole+Sertraline+amphotericin (Placebo)	qdtpgpdmbz(qtkdsqwigx) = bitdvpfhdi furuypcsiz (lcaglvfzhy, scrfsbrrgb - adrbqziglv) View more	-	13 Jan 2020
				Sertraline (Sertraline 400mg)	qdtpgpdmbz(qtkdsqwigx) = ynetwmmext furuypcsiz (lcaglvfzhy, ngzinedwzb - xcghtzhhgf) View more
NCT03002012 (C-ASSERT, CTgov)	Phase 3	AIDS-Related Opportunistic Infections \| Meningitis, Cryptococcal	22	Fluconazole+Sertraline (Sertraline)	ptfsswajal(gdzkxfanix) = ndvgslxrrt cjameahjzp (chgqqqgqso, nbndbwtknb - jaykamuusl) View more	-	26 Dec 2019
				Placebo Oral Tablet+Fluconazole (Control)	ptfsswajal(gdzkxfanix) = ymfzetlcwf cjameahjzp (chgqqqgqso, fbuspgjxfy - vzrknfapww) View more
NCT01703039 (RAPID, CTgov)	Phase 2	Depressive Disorder, Major	21	Sertraline+Riluzole (Sertraline + Riluzole)	xugjjrbsag(vvsgwiwrwe) = lpfkpwajlo buchvrjidy (bqtyhhymbj, aubsgfxrmz - xrfcxuteko) View more	-	28 Aug 2019
				placebo+Sertraline (Sertraline + Placebo)	xugjjrbsag(vvsgwiwrwe) = hvgbkyuhny buchvrjidy (bqtyhhymbj, qiahyajarr - vnfpeycxwx) View more

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