Efficacy and safety of Desvenlafaxine Succinate Sustained-release Tablets in Peri-menopausal and Postmenopausal Women with Major Depressive Disorder: A single-arm, Multicenter, Real-world Study

Start Date29 Nov 2024

Sponsor / Collaborator-

CTR20241827

/ CompletedNot Applicable

琥珀酸去甲文拉法辛缓释片人体生物等效性研究

[Translation] Study on the bioequivalence of desvenlafaxine succinate sustained-release tablets in healthy volunteers

主要研究目的：研究空腹/餐后状态下单次口服受试制剂琥珀酸去甲文拉法辛缓释片（规格：25mg，宜昌人福药业有限责任公司生产）与参比制剂琥珀酸去甲文拉法辛缓释片（商品名：Pristiq ，规格：25mg；PF PRISM CV持证）在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评价受试制剂琥珀酸去甲文拉法辛缓释片25mg和参比制剂琥珀酸去甲文拉法辛缓释片（商品名：Pristiq）25mg在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation desvenlafaxine succinate sustained-release tablets (specification: 25 mg, produced by Yichang Renfu Pharmaceutical Co., Ltd.) and the reference preparation desvenlafaxine succinate sustained-release tablets (trade name: Pristiq, specification: 25 mg; PF PRISM CV certified) in healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study: to evaluate the safety of the test preparation desvenlafaxine succinate sustained-release tablets 25 mg and the reference preparation desvenlafaxine succinate sustained-release tablets (trade name: Pristiq) 25 mg in healthy subjects.

Start Date04 Apr 2024

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

CTR20232944

/ CompletedNot Applicable

琥珀酸去甲文拉法辛缓释片在中国健康受试者中单中心、随机、开放、单次给药、两制剂、两周期交叉人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period crossover bioequivalence study of desvenlafaxine succinate extended-release tablets in Chinese healthy subjects

主要研究目的：以植恩生物技术股份有限公司生产的琥珀酸去甲文拉法辛缓释片（规格：50mg）为受试制剂（T），按有关生物等效性试验的规定，以持证商为PF Prism CV的琥珀酸去甲文拉法辛缓释片（规格：50mg，商品名：Pristiq®）为参比制剂（R）进行生物等效性试验。次要研究目的：观察受试制剂和参比制剂琥珀酸去甲文拉法辛缓释片在健康受试者中的安全性。

[Translation]

The main purpose of the study was to use the desvenlafaxine succinate sustained-release tablets (specification: 50 mg) produced by Zhien Biotechnology Co., Ltd. as the test preparation (T), and the desvenlafaxine succinate sustained-release tablets (specification: 50 mg, trade name: Pristiq®) produced by the licensee PF Prism CV as the reference preparation (R) for bioequivalence testing according to the relevant provisions of bioequivalence testing. Secondary purpose of the study was to observe the safety of the test preparation and the reference preparation desvenlafaxine succinate sustained-release tablets in healthy subjects.

Start Date20 Nov 2023

Sponsor / Collaborator

Chongqing Zhi'en Pharmaceutical Co., Ltd.

100 Clinical Results associated with Desvenlafaxine succinate monohydrate

100 Translational Medicine associated with Desvenlafaxine succinate monohydrate

100 Patents (Medical) associated with Desvenlafaxine succinate monohydrate

1,196

Literatures (Medical) associated with Desvenlafaxine succinate monohydrate

01 Mar 2025·ENVIRONMENTAL RESEARCH

Pilot-scale adsorption of pharmaceuticals from municipal wastewater effluent using low-cost magnetite-pine bark: Regeneration/enumeration of viable bacteria with a study on their biotoxicity

Article

Author: Risteelä, Sofia ; Mohammadzadeh, Mahdiyeh ; Brandt, Kristian Koefoed ; Bello, Adedayo ; Lassen, Simon Bo ; Leiviskä, Tiina

A low-cost and renewable magnetite-pine bark (MPB) sorbent was evaluated in continuous-flow systems for the removal of various pharmaceuticals from municipal wastewater effluent following membrane bioreactor (MBR) treatment. A 33-day small-scale column test (bed volume: 791 cm³) was conducted using duplicate columns of biochar (BC, Novocarbo) and activated carbon (AC, ColorSorb) as reference for two columns of BC and MPB in order to compare the efficiency of AC and MPB. After the small-scale column test, the pharmaceutical concentrations were generally below the detection limit. In the next stage, a four-month pilot-scale adsorption test was performed using a large column (bed volume: 21 L) filled with BC and MPB. A variety of compounds were removed after the pilot-scale column, including trimethoprim (99.7%), hydrochlorothiazide (81.8%), candesartan (26.0%), carbamazepine (86.1%), ketoprofen (89.4%), clindamycin (86.6%), oxazepam (91.3%), sulfadiazine (38.6%), sulfamethoxazole (58.3%), tramadol (88.9%), zopiclone (73.5%), venlafaxine (93.7%), furosemide (93.5%), fexofenadine (91.6%) and losartan (81.2%). The enumeration of viable bacteria in the pilot-scale column samples revealed that regenerating the BC-MPB bed with NaOH increased bacterial counts in the treated water due to the desorption of adsorbed bacteria from the bed. A biotoxicity study using the Nitrosomonas europaea bioreporter strain indicated that the wastewater was generally non-toxic to this nitrifying bacterium and regeneration of pilot-scale column samples caused short-time toxicity immediately after regeneration. The study confirms that MPB is efficient for the adsorption of pharmaceuticals and can be applied in column mode with a support material such as BC. Therefore, MPB is a viable alternative for AC for the remediation of pharmaceutical-contaminated wastewaters.

01 Mar 2025·ANALYTICA CHIMICA ACTA

Expanding the chemical coverage of polar compounds in water analysis by coupling supercritical fluid with hydrophilic interaction chromatography high-resolution mass spectrometry

Article

Author: Holmark, T ; Emke, E ; Amato, E D ; Gargano, A F G ; Cerrato, A

BACKGROUND:

Persistent and mobile organic compounds (PMOC) are of great concern for water quality and human health. The recent improvement and availability of high-resolution mass spectrometry in combination with liquid chromatography have widely expanded the potential of analytical workflows for their detection and quantitation in water. Given their high polarity, the detection of some PMOC requires alternative techniques to reversed-phase chromatography, such as hydrophilic interaction liquid chromatography (HILIC) and supercritical fluid chromatography (SFC). Unified chromatography (UC), an SFC gradient in which the state of the mobile phase changes continuously from supercritical to liquid at 100 % polar co-solvent, has shown potential for the analysis of compounds in a broad range of polarity, including very polar compounds.

RESULTS:

In the present study, for the first time, a UC-HILIC method coupled with high-resolution mass spectrometry was set up for PMOC analysis in water. SFC and HILIC gradients were run sequentially on the same bare-silica column, with the first separation running to 100 % modifier (UC) followed by a HILIC gradient transitioning to water. The UC and UC-HILIC gradients were previously optimized on a mix of 18 representative PMOC to assess solvent and mobile phase composition and for the instrumental system setup. The final method was employed for the analysis of water samples in comparison with a traditional reversed-phase separation, resulting in a significant increase in the number of annotated polar PMOC, including compounds listed in the Candidate List of substances of very high concern for Authorisation by the European Chemicals Agency.

SIGNIFICANCE:

The proposed approach represents a robust alternative to traditional methods for broadening the chemical space of separation and mass spectrometric detection. The introduction of the HILIC section of the gradient was necessary for the elution of strongly retained compounds on the silica phase, thus also reducing the amount of compounds that would be permanently bound onto the phase of the column, resulting in possible irreproducibility, pressure increase, and loss of efficiency in the compound separation.

01 Mar 2025·ENVIRONMENTAL POLLUTION

Comprehensive analysis of pharmaceutical and illicit drugs contamination in thermal swimming pools: Occurrence, distribution, and potential impact

Article

Author: Drdanová, Alexandra Paulína ; Svitková, Veronika ; Fehér, Miroslav ; Grabic, Roman ; Tulipánová, Alexandra ; Nemčeková, Katarína ; Staňová, Andrea Vojs ; Krivoňáková, Naďa ; Ryba, Jozef ; Mackuľak, Tomáš ; Imreová, Zuzana ; Šípoš, Rastislav

The contamination of aquatic environments by micropollutants, including pharmaceuticals and illicit drugs, is a growing global issue with significant implications for environmental and public health. This study addresses a critical knowledge gap by examining pharmaceutical and drug contamination in thermal swimming pools, which are often legally discharged into water bodies without treatment. A total of 49 water samples from 19 distinct thermal pools were analysed, targeting 101 compounds, including pharmaceuticals, illicit drugs, and their metabolites. High-frequency contaminants were identified including caffeine, theophylline, cardiovascular medications (bisoprolol, metoprolol, telmisartan), antidepressants (venlafaxine, citalopram), antihistamines (cetirizine, diphenhydramine), the analgesic tramadol, the antiepileptic carbamazepine, and the illicit drug methamphetamine. The study revealed that these substances were present in more than 30% of the samples, with some occurring at relatively high maximum concentrations, e.g. caffeine (69 μg/L), and methamphetamine (1.8 μg/L). Notably, certain categories of targeted micropollutants, such as cardiovascular medications and illicit drugs, were found to be more prevalent in specific pools. A higher occurrence of cardiovascular drugs has been observed in a pool predominantly designed for relaxation and thus probably preferred by older people. In this pool also notably high levels of illicit drugs were found. The presence of illegal drugs was also confirmed in the children's pool. This study contributes valuable insights into the patterns of micropollutant distribution in thermal pools and emphasises the necessity for enhanced monitoring and management strategies to mitigate environmental and public health risks posed by micropollutants, as well as the possible further impact on aquatic ecosystems.

News (Medical) associated with Desvenlafaxine succinate monohydrate

25 Nov 2024

·www.prnewswire.com

Major Depressive Disorder Market to Register Immense Growth by 2034 Owing to a Robust Pipeline | DelveInsight

With the anticipated introduction of new treatments such as COMP360 (COMPASS Pathways), Zuranolone (SAGE Therapeutics/Biogen), LY03005 (Luye Pharma), REL-1017 (Relmada Therapeutics), Seltorexant (Minerva Neurosciences/Janssen Pharmaceutical), ABV-1504 (BioLite/ABVC BioPharma), and other and increasing disease awareness, it's reasonable to expect a significant transformation in the major depressive disorder market in the coming years. LAS VEGAS, Nov. 25, 2024 /PRNewswire/ -- Major depressive disorder (MDD), commonly referred to as depression, is a serious medical condition that affects a person's mood, behavior, thinking, and physical well-being. It is different from the temporary feelings of sadness that everyone experiences and should not be confused with the deep grief following the loss of a loved one. MDD is typically a recurrent and episodic condition, meaning that someone who has experienced depression and recovered is likely to face additional episodes, often within 2 to 3 years. As per DelveInsight analysis, the total diagnosed prevalent cases of MDD in the 7MM were found to be approximately 44 million cases in 2023, which is expected to increase during the forecast period (2024–2034). Among the severity-specific diagnosed prevalent cases of MDD, the highest prevalence was observed in moderate cases accounting for approximately 17 million cases in the 7MM in 2023 followed by severe cases and mild cases. Major depressive disorder can be addressed through several treatment approaches, including pharmacological interventions, psychotherapy, interventional methods, and lifestyle changes. Initial treatment often involves either medication, psychotherapy, or a combination of both, with combined therapy proving more effective than using either alone. For severe cases of major depression, electroconvulsive therapy is the most effective option. The current range of recommended pharmacological treatments for major depressive disorder primarily includes antidepressants such as monoamines, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), and selective reuptake inhibitors, including medications like VRAYLAR, BRINTELLIX (now TRINTELLIX), SPRAVATO, REXULTI, and FETZIMA. In the upcoming major depressive disorder treatment market landscape, there are a plethora of companies investigating agents for use in major depressive disorder which includes Sage Therapeutics, Relmada Therapeutics, Johnson & Johnson Services, Inc., Biogen, COMPASS Pathways, Luye Pharma, and others. Many more pharma companies are conducting clinical trials for therapies for major depressive disorder. To know more about upcoming major depressive disorder therapies showing positive results, visit @ Drugs for Major Depressive Disorder Treatment DelveInsight estimates that the market size for major depressive disorder is expected to grow from USD 7.1 billion in 2023 with a significant CAGR by 2034. The disease awareness and the emergence of new products in the pipeline will add to the market growth in the future. In addition, persistently rising cases of MDD in the forecast period will contribute to the rise in the MDD treatment market. The current pipeline for major depressive disorder includes a range of drugs with diverse mechanisms of action (MoA). COMP360 (COMPASS Pathways) , Zuranolone (SAGE Therapeutics/Biogen) , LY03005 (Luye Pharma) , REL-1017 (Relmada Therapeutics) , seltorexant (Minerva Neurosciences/Janssen Pharmaceutical) , ABV-1504 (BioLite/ABVC BioPharma), and some others are the most promising drugs of this indication. Ongoing research and current trials have the potential to change the MDD market. Keen to know how the MDD market will evolve by 2034? Find out @ Major Depressive Disorder Market Report The potential for effective major depressive disorder treatment in the future is expected to grow with the addition of numerous drugs to the pipeline of new therapeutics. Currently, a variety of candidate drugs for the treatment of major depressive disorder are being tested in various clinical trials, with some showing positive results. Any drug approved with increased safety and efficacy is expected to cause significant changes in the overall major depressive disorder market. Now, let's examine the pipeline therapies under investigation for major depressive disorder COMP360: COMPASS Pathways Phase III COMPASS Pathways is investigating the use of its experimental psilocybin therapy, COMP360, for treating serious mental health conditions like major depressive disorder. COMP360 is a synthesized version of psilocybin, the active compound found in certain "magic mushrooms," and is administered alongside psychological support. Psilocybin has shown promise in therapeutic applications, and COMP360 has been granted Breakthrough Therapy status by the US FDA as well as an Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Currently, COMPASS Pathways is running a Phase II trial for MDD, with a Phase III trial underway in partnership with Massachusetts General Hospital to further explore its potential in meeting mental health treatment needs. The company is anticipated to release top-line data from two key trials, COMP005 and COMP006, by the fourth quarter of 2024 and mid-2025, respectively, for the treatment of TRD. Zuranolone: SAGE Therapeutics/Biogen Phase III Zuranolone, being developed by SAGE Therapeutics and Biogen, is a next-generation oral, highly potent, and selective positive allosteric modulator, designed for specific targeting of synaptic and extrasynaptic GABAA receptors. The binding sites for neuroactive steroids (NASs) are different from those for GABA, benzodiazepines, and barbiturates. The GABA system, which is the primary inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function. SAGE-217 is currently in phase III clinical development for major depressive disorder and is being evaluated through the LANDSCAPE and NEST clinical trial programs, which include multiple studies involving thousands of participants, with varying dosing regimens, clinical endpoints, and treatment approaches. In February 2023, the US FDA accepted the New Drug Application (NDA) for zuranolone in the treatment of MDD. However, in August 2023, the FDA issued a Complete Response Letter (CRL) regarding the NDA for zuranolone for treating adults with MDD. Sage and Biogen are now assessing the feedback and determining their next steps. LY03005: Luye Pharma LY03005, developed by Luye Pharma, is one of the company's key products in the CNS therapeutic space. It is their exclusive extended-release tablet formulation of ansofaxine hydrochloride, a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI) designed for treating major depressive disorder. LY03005 aims to offer improved efficacy and fewer side effects compared to conventional antidepressants like SSRIs and SNRIs. Ansofaxine, a prodrug of desvenlafaxine, strongly inhibits dopamine reuptake in addition to serotonin and norepinephrine, demonstrating superior efficacy in clinical trials. In March 2020, the US FDA accepted the NDA submission for LY03005, which is currently in Phase III pivotal clinical trials for MDD treatment. Seltorexant: Minerva Neurosciences/Janssen Pharmaceutical Phase III Seltorexant, developed by Minerva Neurosciences and Janssen Pharmaceutical, is a selective orexin-2 receptor antagonist intended as an adjunctive treatment for major depressive disorder and for managing insomnia. It is the most advanced ORX2-specific molecule in clinical development, acting as an antagonist by binding to its receptor. Seltorexant is being studied for two main uses: insomnia without psychiatric disorders and MDD in patients who do not respond adequately to SSRIs or SNRIs. In May 2024, Johnson & Johnson reported positive topline results from the pivotal Phase III MDD3001 trial, which assessed its efficacy and safety as an add-on therapy to antidepressants in adults and elderly MDD patients. Discover which therapies are expected to grab major MDD market share @ New Treatments for Major Depressive Disorder REL-1017: Relmada Therapeutics Phase III REL-1017, being developed by Relmada Therapeutics, is a novel chemical entity (NCE) and an NMDA receptor (NMDAR) channel blocker that specifically targets overactive channels while preserving normal glutamatergic neurotransmission. The U.S. FDA has granted it Fast Track Designation as an immunotherapy for treating major depressive disorder. In a Phase II trial, REL-1017 exhibited rapid, strong, and lasting antidepressant effects, with statistically significant improvements over placebo in depression measures. The study also indicated a favorable safety, tolerability, and pharmacokinetic profile for the drug. Currently, it is in late-stage development for MDD, being tested in Phase III trials for both adjunctive and monotherapy. In June 2024, Relmada published clinical data from the Reliance I Study. The company is actively enrolling patients in ongoing trials for REL-1017, including Reliance II (Study 302), with top-line results expected in the latter half of 2024, and Relight (Study 304), which is anticipated to provide results about six months after the completion of Study 302. ABV-1504: ABVC BioPharma Phase II ABV-1504, developed by ABVC BioPharma, features PDC-1421 as its active ingredient and is classified as a botanical investigational new drug. Through its subsidiary BioLite, ABVC has completed a Phase II trial of ABV-1504, a botanical Norepinephrine Transporter (NET) inhibitor. This trial, conducted at Stanford University, showed that the PDC-1421 capsule was safe and well-tolerated among six enrolled adult patients. Both low and high doses of PDC-1421 successfully achieved the study's primary endpoints, showing a necessary 40% improvement in ADHD-RS-IV test scores. In April 2023, PDC-1421 was awarded a US patent (US 11,554,154 B2) for the treatment of Major Depressive Disorder (MDD). The drug has also completed a Phase II trial in MDD patients, and the company intends to hold an End of Phase II (EOP II) meeting with the FDA in the near future. Itruvone (PH10): VistaGen Therapeutics Phase II Itruvone (PH10), being developed by VistaGen Therapeutics, is an investigational first-in-class synthetic neurosteroid that is odorless and fast-acting, showing promise for various neuropsychiatric conditions related to depression and suicidal thoughts. VistaGen is focusing on PH10 as a potential quick-acting, non-sedating, and non-addictive treatment for MDD that patients can conveniently self-administer at home. When self-administered, a microgram-level dose of PH10 sprayed into the nose interacts with nasal chemosensory receptors, activating brain neural circuits to produce rapid antidepressant effects without the side effects, systemic exposure, or safety issues associated with FDA-approved treatments for MDD, such as oral antidepressants and esketamine. After successfully completing Phase IIa trials for MDD, VistaGen is now gearing up for the planned Phase IIb clinical development of PH10 for this condition. Moreover, in December 2022, PH10 received fast-track designation from the US FDA. LPCN 1154: Lipocine Phase II LPCN 1154, developed by Lipocine, is an oral formulation of brexanolone designed for rapid relief of postpartum depression. Its active ingredient is a naturally occurring positive allosteric modulator of the GABAa receptor. This medication is intended to provide an "at-home" treatment option, making it more accessible than the current standard care, which involves invasive procedures and hospitalization. In September 2022, the FDA approved Lipocine's proposal to demonstrate the efficacy of LPCN 1154 through a single pivotal pharmacokinetic bridge to the approved IV infusion of brexanolone via a 505(b)(2) NDA submission. In June 2024, Lipocine announced positive topline results from a pivotal pharmacokinetic study, confirming that LPCN 1154 is bioequivalent to IV brexanolone for PPD treatment. Lipocine aims to submit the NDA by the end of the fourth quarter of 2024. Discover more about drugs for major depressive disorder in development @ Major Depressive Disorder Clinical Trials DelveInsight's latest published market report titled as Major Depressive Disorder Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the major depressive disorder country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The major depressive disorder market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of MDD Gender-specific Diagnosed Prevalent Cases of MDD Severity-specific Diagnosed Prevalent Cases of MDD The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM major depressive disorder market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this major depressive disorder market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the major depressive disorder market. Also, stay abreast of the mitigating factors to improve your market position in the major depressive disorder therapeutic space. Related Reports Major Depressive Disorder Pipeline Major Depressive Disorder Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key major depressive disorder companies, including GH Research, Praxis Precision Medicines, AbbVie, Gedeon Richter, Intra-Cellular Therapies, Bristol-Myers Squibb, Relmada Therapeutics, SAGE Therapeutics, Janssen Research & Development, Minerva Neurosciences, Takeda, Neurocrine Biosciences, Pherin Pharmaceuticals, among others. Treatment-Resistant Depression Market Treatment-Resistant Depression Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key TRD companies, including Navitor Pharmaceuticals, Supernus Pharmaceuti, Novartis, Relmada Therapeutics, Beckley Psytech, COMPASS Pathways, Axsome Therapeutics, Celon Pharma, among others. Treatment-Resistant Depression Pipeline Treatment-Resistant Depression Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key treatment-resistant depression companies, including Axsome Therapeutics, COMPASS Pathways, Merck Sharp & Dohme Corp., Navitor Pharmaceuticals, Inc., Taisho Pharmaceutical Co., Ltd., GH Research Limited, Novartis Pharmaceuticals, Reckitt Benckiser LLC, Relmada Therapeutics, Inc., SAGE Therapeutics, Navitor Pharmaceuticals, Sumitomo Dainippon Pharma, Alkermes, AbbVie, Janssen Pharmaceuticals, Celon Pharma, ACADIA Pharmaceuticals, Pherin Pharmaceuticals, ATAI Life Sciences, among others. Postpartum Depression Market Postpartum Depression Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key postpartum depression companies, including Sage Therapeutics, Epharmix, Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Clinical ResultFast TrackBreakthrough Therapy

06 Jun 2024

·www.drugs.com

Many Patients Have Discontinuation Symptoms After Stopping Antidepressants

THURSDAY, June 6, 2024 -- A considerable proportion of patients have discontinuation symptoms (e.g., dizziness, headache, nausea, insomnia, and irritability) after discontinuing antidepressants, according to a review published online June 5 in The Lancet Psychiatry . Jonathan Henssler, M.D., from the University of Cologne in Germany, and colleagues conducted a systematic review to examine the incidence of antidepressant discontinuation symptoms in patients discontinuing both antidepressants and placebo. Studies investigated cessation or tapering of an established antidepressant drug or placebo among patients with mental, behavioral, or neurodevelopmental disorders. Data were included from 79 studies with 21,002 patients: 16,532 patients discontinued from an antidepressant and 4,470 discontinued from placebo. The researchers found that the incidence of at least one antidepressant discontinuation symptom was 0.31 and 0.17 in 62 study groups after discontinuation of an antidepressant and 22 study groups after discontinuation of placebo, respectively. The summary difference in incidence was 0.08 between antidepressant and placebo groups of included randomized controlled trials. The incidence of severe antidepressant discontinuation symptoms was 0.028 and 0.006 after discontinuation of an antidepressant and placebo, respectively. Higher frequencies of discontinuation symptoms were seen in association with desvenlafaxine, venlafaxine, imipramine, and escitalopram, while higher severity of symptoms was seen in association with imipramine, paroxetine, and either desvenlafaxine or venlafaxine. Substantial heterogeneity was seen for the results. "Evidence that about one in 35 patients suffers from severe antidepressant discontinuation symptoms must be considered preliminary at present, but caution towards severe antidepressant discontinuation symptoms seems to be warranted when discontinuing imipramine, paroxetine, or desvenlafaxine and venlafaxine," the authors write. Abstract/Full Text Editorial (subscription or payment may be required) Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultClinical Study

06 Jun 2024

·www.sciencedaily.com

Antidepressants: New data on prevalence of discontinuation symptoms

How hard is it to stop taking antidepressants? If countless Internet posts and a number of scientific studies are to be believed, discontinuing these medications is highly problematic, and doctors often underestimate the difficulties involved. But it is unclear how common discontinuation symptoms actually are. Researchers have now conducted a systematic review and meta-analysis. They conclude that one in three people reports symptoms after discontinuing antidepressant treatment, but half of those symptoms are attributable to negative expectations (the nocebo effect). How hard is it to stop taking antidepressants? If countless Internet posts and a number of scientific studies are to be believed, discontinuing these medications is highly problematic, and doctors often underestimate the difficulties involved. But it is unclear how common discontinuation symptoms actually are. Researchers from Charité -- Universitätsmedizin Berlin and University Hospital Cologne have now conducted a systematic review and meta-analysis. In their article in The Lancet Psychiatry,* they conclude that one in three people reports symptoms after discontinuing antidepressant treatment, but half of those symptoms are attributable to negative expectations (the nocebo effect). According to the formal definition, antidepressants are not habit-forming. Unlike "true" addictive substances, for example, taking them does not cause the body to require higher and higher doses to achieve the same effect. Even so, many patients report symptoms such as dizziness, headache, or insomnia when they stop taking these mood medications. The phenomenon went largely unremarked by researchers for years, but there are now a relatively large number of studies seeking to quantify the extent of discontinuation symptoms. "The results of these studies vary, in some cases widely," says Prof. Christopher Baethge, a researcher at the Department of Psychiatry and Psychotherapy at University Hospital Cologne and the Faculty of Medicine at the University of Cologne. "There has been a great deal of discussion, some of it quite emotional, within the research community and the general public alike in recent years about how prevalent and severe the discontinuation symptoms actually are." A look at prescription figures shows just how relevant this topic is. According to the most recent Arzneiverordnungs-Report, which summarizes data on drug prescriptions, nearly 1.8 billion daily doses of antidepressants were prescribed in Germany in 2022. Comprehensive meta-analysis brings clarity To answer that question more reliably than before, a team led by Christopher Baethge and Dr. Jonathan Henssler, head of the Evidence-Based Mental Health research group at the Department of Psychiatry and Neurosciences at Charité, conducted a systematic review of existing studies and re-analyzed them in what is known as a meta-analysis. As the first study of its kind, it provides the soundest assessment to date of the consequences of stopping antidepressant treatment. "Our analysis shows that on average, one in three people will experience symptoms after stopping antidepressant treatment," Henssler says. "However, only half of these symptoms are in fact attributable to the drug itself." For their paper, the researchers reviewed more than 6,000 studies. They then selected 79 of them and re-analyzed the results of those trials using statistical methods. In the end, they analyzed data on about 21,000 people, who had received either an antidepressant or a placebo and then been surveyed regarding the prevalence of discontinuation symptoms. Some 31 percent of the patients treated with an active drug reported discontinuation symptoms, but so did 17 percent of those who had received a placebo alone. One in six or seven people experiences true discontinuation symptoms "Drug effects can be ruled out in the placebo group, which means the symptoms either arose by chance, independently of the treatment, or they are the product of the nocebo effect," Henssler explains. The nocebo effect is often considered the mirror image of the placebo effect. It explains the observation that inactive treatments can be associated with "side effects." These effects are triggered purely by the expectation that the treatment that people think they are receiving will have negative effects. "When we take non-specific symptoms and the effect of expectations into account, about one in six or seven people is affected by discontinuation symptoms that occur as an actual consequence of antidepressant medication," Henssler says, summing up the study's results. "In most cases, the symptoms are mild. The vast majority of those affected will be able to discontinue antidepressants without relevant symptoms. This means that in most cases, there is no need for a lengthy or gradual tapering process." Severe symptoms are rare The study found that severe discontinuation symptoms are experienced by one in 35 people, or nearly three percent of those affected. These kinds of symptoms were more common after discontinuing treatment with the drugs imipramine, paroxetine, venlafaxine, and desvenlafaxine. There was not yet enough information on hand for the researchers to assess the situation for a number of widely used antidepressants. As Baethge points out, "It's important for all people wishing to discontinue treatment with antidepressants to be monitored and counseled by healthcare professionals and to receive individual support in the case of withdrawal symptoms. Joint decision-making between the patient and prescriber even before a course of treatment begins is the foundation of good treatment. We hope our data will support patients and healthcare professionals and help alleviate some of the uncertainty surrounding these issues today." About the study The 79 studies considered in the meta-analysis included both randomized placebo-controlled trials and observational studies conducted without a control group. Of the 21,002 patients involved in the studies, 16,532 had received an antidepressant, and 4,470 a placebo. In addition to the researchers from Charité and University Hospital Cologne, researchers at the Medical Center -- University of Freiburg and University Hospital Carl Gustav Carus, in Dresden, were involved in the meta-analysis.

Clinical Result

100 Deals associated with Desvenlafaxine succinate monohydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D02570 D07793	Desvenlafaxine succinate monohydrate	N06AX23	DB06700

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hot Flashes	Mexico	Pfizer Inc.	15 Oct 2009
Depressive Disorder	Canada	Pfizer Canada ULC	05 Mar 2009
Depressive Disorder, Major	United States	PF Prism CV	29 Feb 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Major depressive disorder, moderate (MDD)	Phase 3	China	Wyeth AB	01 Jul 2007
Major depressive disorder, moderate (MDD)	Phase 3	India	Wyeth AB	01 Jul 2007
Major depressive disorder, moderate (MDD)	Phase 3	South Korea	Wyeth AB	01 Jul 2007
Major depressive disorder, moderate (MDD)	Phase 3	Taiwan Province	Wyeth AB	01 Jul 2007
Fibromyalgia	Phase 3	United States	Wyeth AB	01 Aug 2006
Diabetic peripheral neuropathic pain	Phase 3	-	Wyeth AB	01 Jul 2006
Diabetic peripheral neuropathy	Phase 3	United States	Wyeth AB	01 Mar 2006
Pain	Phase 3	United States	Wyeth AB	01 Mar 2006
Sleep Disorders, Intrinsic	Phase 3	-	Wyeth AB	01 Sep 2004
Vasomotor symptom	Phase 3	-	Wyeth AB	01 Sep 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04345471 (CTgov)	Phase 3	Depressive Disorder, Major	615	Placebo (Placebo)	izudxvdcdg(uvlqgtpzat) = mxbkncmqsi secdcmntzr (triztrtkpz, 0.7) View more	-	29 Feb 2024
				Desvenlafaxine 50 mg (MD-120 50 mg)	izudxvdcdg(uvlqgtpzat) = xqvbymseqj secdcmntzr (triztrtkpz, 0.7) View more
NCT01371734 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	363	placebo (Placebo)	fbnhdqbang(wtzskimsry) = faajrzxiza enytczmmwa (whojcbhthz, 1.13) View more	-	20 Mar 2017
				DVS SR (DVS SR Low Dose)	fbnhdqbang(wtzskimsry) = gdvggokggn enytczmmwa (whojcbhthz, 1.12) View more
NCT01371721 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	269	Placebo (Placebo / DVS SR)	glrnnjthiy = ozvnsfscsu cbegfydwna (qufpeeimse, qnuklfzqib - qclksopenf) View more	-	08 Feb 2017
				DVS SR+Fluoxetine (Fluoxetine / DVS SR)	glrnnjthiy = cgcbuznxml cbegfydwna (qufpeeimse, bymigzafgb - ktlqaerxil) View more
NCT01371708 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	283	Placebo+DVS-SR (Placebo/DVS-SR)	iumuepkhcc = bavdwqxone hdbzxaberx (eaatgjdnvj, xmkbwsbgwr - hffqrxwjxx) View more	-	08 Dec 2016
				DVS-SR (DVS-SR, Low Dose/DVS-SR)	iumuepkhcc = wpxjseytta hdbzxaberx (eaatgjdnvj, djovnmeghy - kvczjgnnzr) View more
NCT01372150 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	340	placebo (Placebo)	dowaunjguz(gukcfilftm) = gtrfyekicc vdychoenrg (uvdxfdnmge, 1.18) View more	-	20 Nov 2015
				fluoxetine (Fluoxetine)	dowaunjguz(gukcfilftm) = fkrykyrips vdychoenrg (uvdxfdnmge, 1.17) View more
NCT01316302 (CTgov)	Phase 4	Phobia, Social \| Generalized anxiety disorder	63	Pristiq (Pristiq)	wzfmaistcc(gfljroahzq) = gbvedllrac fruyyejfxu (tmgccmwuyd, 17.1) View more	-	08 Oct 2014
				Placebo (Placebo)	wzfmaistcc(gfljroahzq) = fkjxwyfbuc fruyyejfxu (tmgccmwuyd, 16.8) View more
NCT01432457 (CTgov)	Phase 4	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	924	placebo	lmuhlamaot(hvrhbxtmif) = sojirxxatu rwubrostgt (xiqxszeujv, 0.42) View more	-	20 Jan 2014
NCT00445679 (CTgov)	Phase 3	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	807	Desvenlafaxine Succinate Sustained-Release (DVS SR) (DVS SR 50)	jpmexanfcm = lcmthhhsxp tnvugsgtdb (knboyepqph, elpznjulwn - xgmoxerqlp) View more	-	03 Nov 2013
				Desvenlafaxine Succinate Sustained-Release (DVS SR) (DVS SR 100)	jpmexanfcm = ngudlwkurv tnvugsgtdb (knboyepqph, hhxqgddhay - lsisfcsugp) View more
NCT00887224 (CTgov)	Phase 3	Depressive Disorder, Major	874	Placebo	yvcjlattgj = lxxxdnkunc rzthwekysi (jyxedwjntc, sqdwptvgbc - jyomjubwuk) View more	-	27 Jun 2012
NCT01121484 (CTgov)	Phase 4	Depressive Disorder, Major	439	placebo	tctxxvqxnh(zulrwwryxq) = mociedpuly pnfsedxvsd (udtltdcewg, 3.51) View more	-	30 Mar 2012

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