#1 Clinical Trials Search in Europe

Tianeptine Sodium

This article discusses a clinical trial investigating the use of Tianeptine Sodium, an atypical antidepressant, for treating patients with Treatment Resistant Depression (TRD). The study aims to evaluate the effectiveness of Tianeptine in patients who have not responded to previous antidepressant treatments and to explore its unique mechanism of action involving the opioid system.

Table of Contents

What is Tianeptine?

Tianeptine Sodium, also known by its brand name Tianeurax, is an atypical antidepressant that has been used clinically in Europe, Asia, and South America since the late 1980s[1]. It’s important to note that this medication is not currently available in the United States. Tianeptine is being studied as a potential treatment for Treatment-Resistant Depression (TRD), which occurs when a person with depression doesn’t respond to at least two different antidepressant treatments[1].

How Tianeptine Works

Tianeptine works differently from other antidepressants currently approved in the United States. While most antidepressants affect brain systems that involve chemicals like serotonin, norepinephrine, and dopamine, tianeptine acts on the opioid system in the brain[1]. Specifically, it acts as an agonist (activator) of the mu-opioid receptor (MOR). This means it binds to and activates these receptors in a way similar to the body’s natural painkillers, enkephalins and endorphins[1].

Clinical Trial Overview

A clinical trial is being conducted to study the effectiveness of tianeptine in treating TRD. This study is taking place at two locations in the United States: the Mood and Anxiety Disorders Program at the Icahn School of Medicine at Mount Sinai (MSSM) and the Stanford Depression Research Clinic at Stanford University School of Medicine (SUSM)[1].

Treatment Details

In this study, participants will receive tianeptine treatment for 8 weeks. The medication, Tianeurax 12.5 mg, will be taken three times a day at 9 AM, 1 PM, and 5 PM[1]. This dosing schedule is designed to maintain consistent levels of the medication in the body throughout the day.

Study Procedures

The study involves several procedures to evaluate how tianeptine affects participants:

  • Depression Assessment: The main measure of the study is the Hamilton Rating Scale for Depression (HRSD), which helps evaluate the severity of depression symptoms and track improvement over time[1].
  • Brain Imaging: Some participants will undergo MRI scans to examine how tianeptine affects brain activity, particularly in response to social situations and pain[1].
  • Genetic Testing: Blood samples will be taken for genetic analysis to help understand how a person’s genes might influence their response to the medication[1].

Potential Benefits

The researchers hope that tianeptine could offer several potential benefits for people with TRD:

  1. New Treatment Option: Tianeptine could provide relief for people who haven’t responded to other antidepressants[1].
  2. Targeting Specific Mechanisms: By focusing on the opioid system, tianeptine might help a specific subgroup of people with depression who have deficits in this system[1].
  3. Understanding Depression: This study could help researchers better understand the different biological factors that contribute to depression, potentially leading to more personalized treatments in the future[1].

Important Considerations

While tianeptine shows promise, it’s important to keep in mind:

  • Experimental Treatment: Tianeptine is not currently approved for use in the United States and is being studied as an experimental treatment[1].
  • Opioid Action: Because tianeptine acts on opioid receptors, there may be concerns about its potential for dependence or misuse. However, it’s important to note that its effects are different from typical opioid drugs[1].
  • Individual Response: As with all medications, the effectiveness and side effects of tianeptine may vary from person to person[1].
Aspect Details
Drug Name Tianeptine Sodium (Tianeurex)
Condition Studied Treatment Resistant Depression (TRD)
Dosage 12.5 mg, 3 times daily (9am, 1pm, 5pm)
Treatment Duration 8 weeks
Participant Age Range 21-60 years
Number of Participants 75
Primary Outcome Measure Hamilton Rating Scale for Depression (HRSD)
Additional Assessments MRI scans, genomic testing
Study Locations Icahn School of Medicine at Mount Sinai, Stanford University School of Medicine

FAQ

  • What is Tianeptine Sodium? Tianeptine Sodium is an atypical antidepressant that has been used in Europe, Asia, and South America since the late 1980s. It works differently from other antidepressants by targeting the mu-opioid receptor in the brain.
  • Who is eligible for this clinical trial? The trial is recruiting participants aged 21-60 with unipolar Major Depressive Disorder (MDD) who have failed at least two adequate treatment trials with standard antidepressants.
  • How long does the treatment last in this trial? Participants will receive an 8-week treatment trial of Tianeptine, taken three times a day (9am, 1pm, 5pm) at a dose of 12.5 mg each time.
  • What tests will be performed during the trial? Participants will undergo various assessments, including the Hamilton Rating Scale for Depression (HRSD). Some participants will also have MRI scans and blood tests for genomic analysis.
  • What are the main goals of this clinical trial? The main goals are to determine if Tianeptine is effective for treatment-resistant depression, to understand the relationship between opioid signaling deficits and response to Tianeptine, and to develop methods for identifying patients with endogenous opioid signaling deficits.

Ongoing Clinical Trials on Tianeptine Sodium

  • Title: Study of tianeptine effectiveness in treating cognitive symptoms (brain fog) in patients who have recovered from COVID-19

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Treatment Resistant Depression (TRD): A condition where a person with depression fails to respond to two or more antidepressant treatments.
  • Tianeptine: An atypical antidepressant that works by targeting the mu-opioid receptor in the brain, unlike traditional antidepressants that affect serotonin, norepinephrine, or dopamine systems.
  • Major Depressive Disorder (MDD): A mental health condition characterized by persistent feelings of sadness, hopelessness, and loss of interest in activities, affecting a person's thoughts, emotions, and behaviors.
  • Mu-opioid receptor (MOR): A type of opioid receptor in the brain that plays a role in pain regulation, reward, and emotional responses. Tianeptine targets this receptor.
  • Magnetic Resonance Imaging (MRI): A medical imaging technique that uses strong magnetic fields and radio waves to create detailed images of the body's internal structures, including the brain.
  • Hamilton Rating Scale for Depression (HRSD): A 24-item questionnaire used to assess the severity of depressive symptoms and monitor recovery in patients with depression.
  • Endogenous opioid signaling: The natural process in the body where opioid-like substances produced by the brain interact with opioid receptors to regulate pain, mood, and emotional responses.
  • Genomic testing: A method of analyzing a person's DNA to identify genetic variations that may contribute to disease susceptibility or influence treatment responses.

References

  1. https://clinicaltrials.gov/study/NCT04249596