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Not recruiting

Tianeptine

Sponsor:

New York State Psychiatric Institute

Code:

NCT04249596

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Interventions

Tianeptine Sodium

Study Details

Brief summary:

The studies will be conducted in parallel at two sites: the the Mood and Anxiety Disorders Program at the Icahn School of Medicine at Mount Sinai (MSSM), and Stanford Depression Research Clinic at Stanford University School of Medicine (SUSM). In addition, MRI studies for the MSSM patients will be carried out at the New York State Psychaitric Institute (NYSPI). The following procedures will be approved by the local Institutional Review Boards (IRBs) at each site, where the site PIs (Alla Landa, PhD, NYSPI, James Murrough, MD at MSSM, and Alan Schatzberg, MD at SUSM) 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 21-60, who have failed at least 2 two adequate treatment trials with a standard antidepressant. Patients will receive an 8-week treatment trial of tianeptine. MSSM patients will also undergo structural and task-based magnetic resonance imaging (MRI) that will be performed under Dr. Landa's direction at NYSPI in order to maintain the internal validity of the data set. MSSM subjects will be transported to NYSPI to complete neuroimaging procedures as described below. Participants will be screened for MRI clearance during their screening visit and again at 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.

Conditions

Treatment Resistant Depression

Study ID

NCT04249596

Start date

Oct 14, 2020

Status verified date

Jul, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 21 - 60 years, male or female
2. Current diagnosis of 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 trials within current episode) with a SSRI, SNRI, bupropion, tricyclic antidepressant, mirtazapine, nefazodone, or monoamine oxidase inhibitor, or transcranial magnetic stimulation (TMS), or IV ketamine or nasal ketamine.
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.
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. for MSSM site - 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.

a) If a participant is taking a protocol dis-allowed medication at the time of screening and despite medication treatment still meets the inclusion criteria of an HRSD>16, the participant may discontinue the medication under the supervision of their treating physician or the study clinician.
16. Positive urine toxicity at screening (except for cannabinoid)

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open Treatment

All subjects will be treated for 8 weeks of treatment with Tianeptine (Tianeurax 12.5 mg) 3 times a day (9am, 1pm, 5pm).

Interventions

Tianeptine Sodium

At baseline, and following 8 weeks of treatment with tianeptine(12.5 mg, 3x daily), participants will be assessed in a number of procedures to evaluate their emotional and physical pain state and pain stimulus response and the relationship of such states/responses to endogenous opioid signaling. To further assess emotional pain, participants will also undergo fMRI while performing a validated social rejection and social acceptance paradigm known to induce endogenous opioid release in control subjects and blunted release in MDD. Examining both rejection and acceptance is important because the MOR system regulates both social distress and social reward in animals and humans, and tianeptine may also act on abnormal MOR-mediated responses to social acceptance in MDD. Likewise, a second fMRI scan will be used to explore physical pain response using an established thermal pain sensitivity task. The protocol at Stanford University will not include pain testing or imaging studies.

Primary outcome measure

  • Hamilton Rating Scale for Depression (HRSD) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Steven Roose, MD

646-774-8661spr2@cumc.columbia.edu

Alla Landa, PhD

646-774-6717al2898@cumc.columbia.edu

Locations

Stanford Depression Research Clinic at Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Jessica Hawkins

650-723-8330jhawk@stanford.edu

Principal Investigator:

Alan Schatzberg, MD

Mood and Anxiety Disorders Program at the Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Amelia Karim

212-585-6133amelia.karim@mssm.edu

Principal Investigator:

James Murrough, M.D.

More Information

Sponsor

New York State Psychiatric Institute

Last update posted

Jul 3, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by New York State Psychiatric Institute on 2024-07-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.