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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study Summary

This trial will test the efficacy of tianeptine, a drug used to treat major depressive disorder, in 75 participants who have failed at least two other treatment trials. The participants will undergo MRI scanning during the course of the trial.

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.Check my 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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hamilton Rating Scale for Depression (HRSD)

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
2,393 Previous Clinical Trials
17,341,211 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
860 Previous Clinical Trials
524,401 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,832 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA have Tianeptine Sodium on its list of approved drugs?

"Tianeptine Sodium is a Phase 4 medication, meaning it has already been approved and thus, our team gives it a safety score of 3."

Answered by AI

Are people still being recruited to participate in this experiment?

"That is correct, the listing on clinicaltrials.gov states that the trial is currently looking for participants. The study was first made public on October 14th 2020 and has been edited most recently on July 18th 2022. They are hoping to enroll 75 patients total from one location."

Answered by AI

How many people are eligible to join this research project?

"That is correct, the information available on clinicaltrials.gov suggests that this study is looking for more participants. This trial was originally posted on October 14th 2020 and was most recently updated on July 18th 2022. Currently, the plan is to recruit 75 patients from 1 medical site."

Answered by AI

Is Tianeptine Sodium a new medication?

"Currently, there are 2 on-going trials for Tianeptine Sodium. No Phase 3 trials have been conducted as of yet. Most research related to this medication occurs in New york City; however, clinical trials are being run in 2 additional locations."

Answered by AI

Does this research require participants to be a certain age?

"This specific trial is only taking applications from people aged 21 to 50. In total, there are 205 clinical trials for patients under 18 and 1002 trials for seniors above the age of 65."

Answered by AI

For which patient population is this trial designed?

"To participate in this experiment, prospective patients must be 21-50 years old and have a diagnosis of melancholia. The study will accept approximately 75 people in total."

Answered by AI

Who else is applying?

What site did they apply to?
1051 Riverside Drive
Stanford Depression Research Clinic at Stanford University School of Medicine
Mood and Anxiety Disorders Program at the Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I’ve tried so many different drugs. Have tried many antidepressants, TMS and Ketamine.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Tianeptine for Treatment Resistant Depression
Jonathan A. Javitch, MD, PhD 2020. "Tianeptine for Treatment Resistant Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04249596.
All > Depression New York
~18 spots leftby Jun 2025
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