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Antidepressant

Tianeptine for Depression

Phase 4
Recruiting
Led By Bret R Rutherford, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current diagnosis of Major Depressive Disorder (MDD) without psychotic features
Age 21 - 60 years, male or female
Must not have
Currently being treated with an antidepressant medication, an antipsychotic or mood stabilizer.
Previous or current treatment with Tianeptine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tests tianeptine, an antidepressant that targets specific brain receptors, on adults with major depressive disorder who haven't responded to other treatments. The goal is to see if tianeptine can help these patients by working on the brain's natural painkiller system. Tianeptine is known for its unique way of working and its ability to protect the brain from stress.

Who is the study for?
This trial is for adults aged 21-60 with Major Depressive Disorder who haven't improved after at least two treatments with common antidepressants or other therapies like TMS or ketamine. Participants must be able to consent, follow study procedures, and use contraception if applicable. Exclusions include a history of opioid or severe substance abuse, psychotic disorders, high suicide risk, previous tianeptine treatment, certain medical conditions including severe obesity that affects MRI scanning eligibility.
What is being tested?
The trial is testing the effectiveness of Tianeptine Sodium in treating people with Treatment Resistant Depression over an 8-week period. It includes MRI scans for some participants to observe brain changes and genetic tests to find links between genes and depression.
What are the potential side effects?
While specific side effects are not listed here, typical antidepressant side effects can range from nausea, headaches, sleep disturbances to more serious ones like increased risk of suicidal thoughts especially in young adults. Patients will be monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Major Depressive Disorder without experiencing psychosis.
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I am between 21 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication for depression, psychosis, or mood stabilization.
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I have been treated with Tianeptine before.
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My depression did not improve after electroconvulsive therapy.
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I have severe depression or thoughts of harming myself.
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I am currently taking opioid medication.
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I do not have any severe or unstable illnesses right now.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hamilton Rating Scale for Depression (HRSD)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open TreatmentExperimental Treatment1 Intervention
All subjects will be treated for 8 weeks of treatment with Tianeptine (Tianeurax 12.5 mg) 3 times a day (9am, 1pm, 5pm).

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER
2,491 Previous Clinical Trials
17,518,994 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
914 Previous Clinical Trials
572,826 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
479 Previous Clinical Trials
153,755 Total Patients Enrolled
Bret R Rutherford, MDPrincipal InvestigatorNew York State Psychiatric Institute
5 Previous Clinical Trials
123 Total Patients Enrolled
Steven Roose, MDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
86 Total Patients Enrolled
Alla Landa, PhDPrincipal InvestigatorNew York State Psychiatric Institute
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Tianeptine Sodium (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT04249596 — Phase 4
Major Depressive Disorder Research Study Groups: Open Treatment
Major Depressive Disorder Clinical Trial 2023: Tianeptine Sodium Highlights & Side Effects. Trial Name: NCT04249596 — Phase 4
Tianeptine Sodium (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04249596 — Phase 4
~15 spots leftby Dec 2025
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