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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
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.
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
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)
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
2,448 Previous Clinical Trials
17,492,319 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
886 Previous Clinical Trials
534,968 Total Patients Enrolled
New York State Psychiatric InstituteLead Sponsor
477 Previous Clinical Trials
153,953 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Major Depressive Disorder without experiencing psychosis.I have been treated with Tianeptine before.I am currently taking medication for depression, psychosis, or mood stabilization.I can stop taking certain medications under doctor's advice if needed for the study.If you are a woman who can have a baby, you need to use birth control during the study.My depression did not improve after electroconvulsive therapy.I am between 21 and 60 years old.You understand what the study involves and agree to follow the rules of the study.You have a high score of 16 or more on the depression rating test called "Hamilton Rating Scale for Depression."I have tried at least two different depression treatments without success.I have severe depression or thoughts of harming myself.I am currently taking opioid medication.I do not have any severe or unstable illnesses right now.
Research Study Groups:
This trial has the following groups:- Group 1: Open Treatment
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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