Evaluation of the Efficacy of Perioperative Administration of Tianeptine Versus Pregabalin on Acute and Chronic Post Mastectomy Pain After Breast Cancer Surgery. A Double-Blinded Randomized Controlled Trial.

Breast cancer is the most common malignancy among females. Nearly 40% of breast surgery patients experience moderate to severe acute postoperative pain, with severe pain persisting for more than 6 months in almost 20-50% of patients (post mastectomy pain syndrome) which is defined according to International Association for the Study of Pain (IASP) as pain which persists more than 3 months after mastectomy/lumpectomy affecting the anterior thorax, axilla, and/or medial upper arm. Different pharmacological tools have been in use for either prevention or treatment of such refractory pain syndrome with variable efficacy. The aim of this study is to assess the efficacy of the perioperative use of Pregabalin versus Tianeptine on the emergence of PMPS in female patients undergoing MRM for breast cancer.

Start Date21 Jun 2023

Sponsor / Collaborator

The National Cancer Institute (Egypt)

NCT06012552 / RecruitingPhase 2IIT

Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of Tianeptine in the Treatment of Covid Fog Symptoms in Patients After COVID-19 With the Study of the Pathophysiology of the Phenomenon Using Positron Emission Tomography, Biochemical, Immunological and Electrophysiological Parameters.

COVID-19 is associated with a high risk of complications from the central nervous system. Syndrome of cognitive disorders- in terms of memory, attention or executive functions among COVID-19 convalescents is often called brain fog (covid fog - CF). CF leads to psychomotor retardation and chronic fatigue syndrome, resulting in poor functioning and low quality of life. CF may affect up to 81% of patients after COVID-19.
Prevalence of CF may be even greater among patients with severe forms of COVID-19. In the preliminary assessment authors found that 83% of COVID-19 inpatients had at least mild cognitive impairment. Moreover, SARS-CoV-2 infection is associated with higher incidence of depression and anxiety disorders. CF pathogenesis is not fully understood. There exist no strict diagnostic criteria for it, as well as no therapeutic recommendations. Health care systems of many countries, including Poland, lack therapeutic programs addressed at patients with CF. Tianeptine may be a drug with potentially beneficial effects in CF. Neuroprotective, antidepressive, sleep-improving and anxiolytic properties of tianeptine allow it to choose as a candidate for CF amelioration. There is also data supporting the thesis that patients with CF may benefit from short-term group therapy. It has been proven to improve quality of life, reduce stress, and improve cognitive function in non-MC cognitive disorders.
Expected research results: A database will be created from the collected clinical, laboratory and additional data. Statistical models will be created to predict: the duration of disorders, response to therapy, the final result of treatment. Among the markers of CNS damage, those which correlates with the patient's condition will be selected.
The study will allow to estimate the prevalence of CF in the population. PET-CT and auditory evoked potentials also will be used to expand knowledge in the field of CF.
Based on the existing data, an improvement is expected in all investigated participants as a result of rehabilitation and psychotherapy.
Additional improvement is expected in the tianeptine group. Improvement will be defined as: reduction in the severity of anxiety and depression disorders, reduction in the severity of cognitive disorders, improvement in the quality of life. The results will be used to develop a new diagnostic and therapeutic pathway and a comprehensive intervention program in CF.

Start Date17 Feb 2023

Sponsor / Collaborator-

NCT04249596 / RecruitingPhase 4IIT

Tianeptine for Treatment Resistant Depression

The studies will be conducted in parallel at two sites: the the Mood and Anxiety Disorders Program at the Icahn School of Medicine at Mount Sinai (MSSM), and Stanford Depression Research Clinic at Stanford University School of Medicine (SUSM). In addition, MRI studies for the MSSM patients will be carried out at the New York State Psychaitric Institute (NYSPI). The following procedures will be approved by the local Institutional Review Boards (IRBs) at each site, where the site PIs (Alla Landa, PhD, NYSPI, James Murrough, MD at MSSM, and Alan Schatzberg, MD at SUSM) will be responsible for overseeing conduct of the study at their respective site. Dr. Jonathan Javitch is the scientific leader of this program and holds the IND for tianeptine use in this study.
Investigators will recruit 75 participants with current unipolar MDD, non-delusional, between 21-60, who have failed at least 2 two adequate treatment trials with a standard antidepressant. Patients will receive an 8-week treatment trial of tianeptine. MSSM patients will also undergo structural and task-based magnetic resonance imaging (MRI) that will be performed under Dr. Landa's direction at NYSPI in order to maintain the internal validity of the data set. MSSM subjects will be transported to NYSPI to complete neuroimaging procedures as described below. Participants will be screened for MRI clearance during their screening visit and again at NYSPI on the day of the scan. Subjects will be asked MRI screening questions to ensure that are scanning eligible. Participants will also have additional tubes of blood drawn for human whole-genomic testing. This microarray will be used to identify regions of the human genome that contribute to disease susceptibility and phenotypes. The Illumina human whole-genome array will be used to provide a comprehensive view of the genome, detects single nucleotide polymorphisms and other variations across the genome.

Start Date14 Oct 2020

Sponsor / Collaborator

The New York State Psychiatric Institute

[+2]

100 Clinical Results associated with Tianeptine Sodium

100 Translational Medicine associated with Tianeptine Sodium

100 Patents (Medical) associated with Tianeptine Sodium

Literatures (Medical) associated with Tianeptine Sodium

04 Jul 2021·The American Journal of Drug and Alcohol AbuseQ3 · MEDICINE

Tianeptine: a new frontier in surveillance and understanding through social media

Q3 · MEDICINE

Article

Author: Rushton, William ; Rivera, Jessica

Interest in the abuse of tianeptine in the United States has been increasing over the past decade (1). The xenobiotic, which is known under the trade name internationally as Stablon or Coaxil, was ...

01 Nov 2018·PsychosomaticsQ4 · MEDICINE

Tianeptine Abuse and Dependence: Case Report and Literature Review

Q4 · MEDICINE

Review

Author: Rahul Lauhan ; Alan Hsu ; Kristin Beizai ; Al Alam

BACKGROUNDTianeptine (Stablon, Coaxil) abuse and dependence has become increasingly prominent worldwide with recent presence in the United States.OBJECTIVEIn this article, we add a case to the growing literature on tianeptine dependence, the first of which is concerning for the presence of an adulterant, and present a comprehensive literature review.METHODSA literature search was conducted on July 2, 2018 on PubMed for articles using the keywords "tianeptine abuse" and "tianeptine dependence."RESULTSLiterature search resulted in 25 articles and encompassed 65 patients. A majority of patients were male and age ranged from 19 to 67. Routes of intake included oral, intravenous, and insufflation. In the 15 cases of overdose, 8 combined ingestion with at least one other substance, of which 3 resulted in death. Six additional deaths are reported involving tianeptine (9 total).CONCLUSIONTianeptine abuse and dependence has become a cause for concern in approved markets with recent emergence in the United States. Psychiatrists should be aware of a potentially fatal opiate-like withdrawal in the absence of positive urine drug screens or cases where withdrawal does not follow expected patterns. Tianeptine users should be educated regarding risk associated with this drug. Without further intervention, additional cases should be anticipated.

01 Sep 2014·Int. Journal of Clinical Pharmacology and TherapeuticsQ4 · MEDICINE

Pharmacokinetic and bioequivalence assessment of two formulations of tianeptine sodium in healthy male volunteers

Q4 · MEDICINE

Article

Author: Kim, Bo-Hyung ; Zheng, Renhua

BACKGROUNDTianeptine is widely used for controlling depressive symptoms.OBJECTIVEThe aim of this study was to evaluate the bioequivalence between the generic (test) formulation containing tianeptine sodium 12.5 mg and the branded (reference) formulation Stablon® with regard to their pharmacokinetic profiles.METHODSA randomized, two-sequence, two-treatment crossover study was conducted in healthy male Korean volunteers. All of the enrolled subjects were allocated to one of two sequence groups. They were administered a tablet of the test or reference formulation and then administered the alternative formulation after a 7-day washout period. The blood samples were taken before dosing and at 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 10 hours after dosing. The plasma concentrations of tianeptine were analyzed using high-performance liquid chromatography with tandem mass spectrometer. Tolerability was assessed throughout the study.RESULTSThe pharmacokinetic parameters were assessed in the 40 subjects who completed the study. The tianeptine C(max) for the test formulation was 283.13 ± 57.58 ng/mL (mean ± SD) and that for the reference formulation was 272.50 ± 59.00 ng/mL. The AUC(last) of tianeptine was 803.24 ± 180.94 ng×h/mL for the test formulation and 792.27 ± 180.93 ng×h/mL for the reference formulation. The geometric mean ratio (%) of the test to reference formulation was 104.04 (90% CI, 99.66 - 108.61) for C(max) and 101.30 (98.01 - 104.71) for AUC(last). Clinically significant adverse events were not reported during the study.CONCLUSIONThe test and reference formulations of tianeptine were bioequivalent with regard to the pharmacokinetic parameters of Cmax and AUC(last). Both formulations were tolerated by all of the participants.

News (Medical) associated with Tianeptine Sodium

12 Sep 2024

·www.prnewswire.com

Feldman Shepherd Files Wrongful Death Lawsuit Against Maker of Neptune's Fix Following Death of 32-Year-Old

PHILADELPHIA , Sept. 12, 2024 /PRNewswire/ -- Plaintiffs' personal injury law firm Feldman Shepherd Wohlgelernter Tanner Weinstock Dodig LLP filed a wrongful death lawsuit on September 5, 2024 on behalf of the family of 32-year-old Matthew Cornier, of Toms River, New Jersey, who died on December 6, 2023, after consuming Neptune's Fix Elixir. The lawsuit was filed in the Superior Court of New Jersey, Middlesex County, against Neptune Resources, LLC; Super Chill CBD Products; and Hometown Market, who are named as manufacturers, distributors and/or sellers of Neptune's Fix. The litigation is led by Feldman Shepherd shareholders John M. Dodig and Jason A. Daria. According to the suit, Neptune's Fix, marketed as a dietary supplement, contains tianeptine, an unapproved antidepressant drug which is advertised as "Happiness in a Bottle." The U.S. Food and Drug Administration has issued warnings about adverse reactions from products containing tianeptine, including seizures, coma and death. In January 2024, after Cornier's death, Neptune Resources voluntarily recalled Neptune's Fix Elixir. New Jersey officials, including U.S. Rep. Frank Pallone, Jr., have highlighted the dangerous and addictive properties of Neptune's Fix and other products containing tianeptine, leading to calls for stricter regulation and enforcement to protect public health. The Ocean County Medical Examiner concluded that Cornier's death was caused by the adverse effect of tianeptine with THC, which the lawsuit attributes to Cornier's consumption of Neptune's Fix. "Matthew Cornier was a devoted and loving son, brother, friend, and fiancé to his longtime girlfriend and soulmate. Matt did not have a history of health issues or addiction. He bought Neptune's Fix thinking that it was a dietary supplement, that it was safe, and that it would help him focus at work as a talented and up-and-coming Graphic Design Artist. He purchased it at a local convenience store, not some back alley. Neptune Resources and other companies that have put tianeptine-containing products into the marketplace must be held legally accountable when their products cause deaths and serious injuries," Dodig said. "No one should die because they drank a small energy drink that they purchased at a local convenience store. We hope that this lawsuit will shine a spotlight on this public health concern and prompt the companies behind products with tianeptine to take immediate action to remove them from the marketplace," Daria said. To download a copy of the complaint CLICK HERE. Mr. Dodig and Mr. Daria may be contacted directly at: John M. Dodig: [email protected] or 215-567-8300 Jason A. Daria: [email protected] or 215-567-8300 About Feldman Shepherd Feldman Shepherd Wohlgelernter Tanner Weinstock Dodig LLP has recovered some of the largest verdicts and settlements in Pennsylvania, New Jersey and several other states across the country. The firm represents plaintiffs in significant personal injury and complex civil litigation including medical malpractice, birth injury, motor vehicle accidents, truck accidents, construction and workplace accidents, defective products, crashworthiness, class actions, and whistleblower claims. SOURCE Feldman Shepherd Wohlgelernter Tanner Weinstock Dodig LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

07 Aug 2024

·www.prnewswire.com

ACCP Position Statement: "Unregulated Psychotropic Products"

ASHBURN, Va., Aug. 7, 2024 /PRNewswire/ -- The American College of Clinical Pharmacology® (ACCP) published a recent Position Paper entitled " Unregulated Psychotropic Products. " Unregulated psychotropics, not approved by the US Food & Drug Administration (FDA) yet widely available and used to induce euphoria and relaxation, pose significant public health risks like addiction, overdose and death. Despite their illegal status, they are available in various forms like pills, powders and extracts at many over-the-counter establishments, gas stations and online websites, leading to their misuse and addiction. Kratom, tianeptine and phenibut are three commonly misused and unregulated psychotropics discussed in this paper, explaining their origins, forms of availability, marketing strategies involved, and opioid-like and other effects based on their pharmacological drug receptor interactions. These interactions lead to serious harm, causing various mild to severe adverse events such as seizures, tremors, impaired cognition, anxiety and deaths from overdose and misuse. This position statement emphasizes the significant health risks and the need for caution with products being misrepresented as dietary ingredients or herbal supplements. It also outlines the existing regulatory measures taken by the US FDA and additional necessary steps to limit the availability of these unregulated products in the market. Building on health risks and regulatory aspects, ACCP urges business establishments to stop selling these unsafe and unregulated psychotropic products. About ACCP ACCP is a non-profit association providing accredited Continuing Education, publications and career-enhancing opportunities to clinical pharmacology healthcare professionals. SOURCE American College of Clinical Pharmacology

20 Jun 2024

·www.biospace.com

Luxor Scientific Unveils Cutting-Edge Testing Solutions to Combat Escalating Illicit Drug Crisis

Greenville, SC June 20, 2024 – Luxor Scientific, a leader in scientific research, announces groundbreaking advancements in combatting the rise of deadly illicit drugs. Leveraging expertise in toxicology, Luxor has developed advanced testing solutions to address the nation’s overdose crises associated with substances like bromazolam, tianeptine, xylazine, and nitazenes, providing healthcare professionals the information needed to develop more effective treatment plans. Bromazolam, often labeled as 'Fake Xanax,' is misrepresented as genuine Xanax, leading to a surge in overdose incidents and widespread concern among healthcare and law enforcement. Consumed orally to alleviate anxiety and panic, bromazolam's availability online exacerbates the risk. Similarly, tianeptine, known as 'gas station heroin,' administered intravenously for a euphoric effect, has recently prompted Louisiana to ban it due to reports of seizures and loss of consciousness. Additionally, the emergence of xylazine, a potent horse tranquilizer mixed with fentanyl, exacerbates the crisis, causing zombie-like behavior in users. Luxor Scientific's innovative testing solutions mark a significant advancement in combating illicit drug proliferation, providing precise detection of hazardous substances in easily collected body fluids. Our commitment to updating our test menu ensures we stay ahead in addressing evolving drug trends. Using state-of-the-art technology and extensive toxicology experience, our testing protocols empower stakeholders to respond effectively, safeguarding public health. Detection of novel illicit drugs is exclusive to experienced labs like Luxor Scientific. Luxor’s ability to detect illicit drug use in urine and oral fluid, along with rapid turnaround times, ensures life-saving results within 24 to 48 hours, critical for immediate intervention in emergency situations. “As a leading force in scientific research and innovation, Luxor Scientific is committed to leveraging our expertise to address pressing societal challenges such as the proliferation of illicit drugs,” stated Dr. Marion Snyder, Chief Science Officer at Luxor Scientific. “Our cutting-edge testing solutions represent a significant milestone in our ongoing efforts to combat the devastating impact of substance use disorder, empowering communities with the tools needed to safeguard public health and effectively treat patients.” Luxor Scientific has the capability to detect over 100 drugs and metabolites, including novel illicits. With an unwavering mission towards scientific excellence and social responsibility, Luxor Scientific is dedicated to effecting positive change in the face of adversity. As communities grapple with the escalating threat posed by novel illicit drugs, Luxor Scientific stands ready to partner with stakeholders across sectors to confront this crisis head-on and build a safer, healthier future for all. Healthcare providers concerned they are not identifying all the illicit substances their patients could be consuming or co-addicted can email Luxor Scientific at clientservices@luxorscientific.org or call 864-568-8940. About Luxor Scientific Luxor Scientific was founded with the mission of providing better information faster. As a full-service privately-held CAP-accredited medical and research laboratory, Luxor offers a robust menu of clinical and anatomical testing services. Today, Luxor Scientific is one of the fastest-growing companies in the southeast, specializing in cutting-edge diagnostic testing solutions in the areas of metabolomics, genomics, toxicology and histology. Luxor’s industry-leading turnaround times and state-of-the-art equipment and diagnostic solutions, allows Luxor to provide personalized service, accurate testing, and innovative functional reporting. For more information about Luxor Scientific and our full test offering, please visit . Media Contact: Kristina Loughrey kristina@klcoms.com 864.360.5848

Diagnostic Reagents

100 Deals associated with Tianeptine Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D08589	Tianeptine Sodium	N06AX14	-

R&D Status

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Indication	Country/Location	Organization	Date
Depressive Disorder	CN	Les Laboratoires Servier SAS	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASTRO	Not Applicable	-	-	Tianeptine (RT)	hclkbfmkkp(gyksxxouwo): P-Value = 120 days View more	-	01 Nov 2018
				Tianeptine + RT

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