Tianeptine for Treatment Resistant Depression

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted in parallel at two sites: the Clinic for Aging, Anxiety and Mood Disorders (CAAM) at Columbia University/New York State Psychiatric Institute (CU/NYSPI) and the Mood and Anxiety Disorders Program at the Icahn School of Medicine at Mount Sinai (MSSM). The following procedures will be approved by the local Institutional Review Boards (IRBs) at each site, where the site PIs (Bret Rutherford, MD at CU/NYSPI and James Murrough, MD at MSSM) 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 21-50, who have failed at least 2 two adequate treatment trials with a standard antidepressant. Participants with only 1 previous adequate treatment trial may receive their second trial at CU/NYSPI before continuing on to main study protocol. Patients will receive an 8-week treatment trial of tianeptine. Patients will also undergo structural and task-based magnetic resonance imaging (MRI) that will be performed under Dr. Rutherford's direction at CU/NYSPI in order to maintain the internal validity of the data set. Approval has been granted for use of the MRI facility for this study by the Director of MRI Research at the New York State Psychiatric Institute. CU/NYSPI and MSSM subjects will be transported to CU/NYSPI to complete neuroimaging procedures as described below. Participants will be screened for MRI clearance during their screening visit and again at CU/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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborators: Icahn School of Medicine at Mount Sinai; Stony Brook University
• Treatments: Tianeptine

Criteria

Inclusion Criteria:

1. Age 21-50 years, male or female

2. Current diagnosis of Unipolar Major Depressive Disorder (MDD) without psychotic features

3. 24-item Hamilton Rating Scale for Depression (HRSD) ≥ 16

4. At least two previous antidepressant treatment failures (adequate trial within current episode) with an SSRI, SNRI, bupropion, tricyclic antidepressant, mirtazapine, nefazodone, monoamine oxidase inhibitor, or transcranial magnetic stimulation (TMS)

5. Capable of providing informed consent and complying with study procedures

6. Currently using or willing to use contraception, if woman of childbearing potential (such as condoms, IUD, or oral contraceptive), for duration of the study

Exclusion Criteria:

1. Any history of opioid-use disorder

2. Any history of moderate- non-opioid (except for Nicotine) substance-use disorder

3. Any severity of alcohol use disorder (including mild)

4. Past or current psychosis, psychotic disorder (including psychotic MDD), mania, or bipolar disorder

5. Hamilton Rating Scale for Depression (HRSD) suicide item > 2 or Clinical Global Impressions (CGI)-Severity score of 7 at baseline

6. Previous or current treatment with tianeptine

7. Current treatment or currently taking an opioid

8. Failed depression treatment with electroconvulsive therapy, intravenous ketamine or esketamine

9. Acute, severe, or unstable medical illness

10. Weight > 300 lbs or girth size incompatible with scanner bore

11. Any physical or intellectual disability adversely affecting ability to complete assessments; MMSE <26

12. Having contraindication to MRI scanning (such as metal in body) or inability to tolerate the scanning procedures (e.g., severe obesity, claustrophobia)

13. Current pregnancy or currently breast feeding

14. Abnormal baseline liver function tests

15. Currently being treated with an antidepressant medication, an antipsychotic or mood stabilizer and not willing to end current treatment

16. Positive urine toxicity at screening (except for cannabinoid)