TERMINATED

Tianeptine for Treatment Resistant Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Tianeptine for Treatment Resistant Depression

Quick Facts

Study Start:2020-10-14

Study Completion:2024-08-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04249596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Alla Landa, PhD

PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Study Locations (Sites)

Stanford Depression Research Clinic at Stanford University School of Medicine

Stanford, California, 94305

United States

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

New York, New York, 10029

United States

New York State Psychiatric Institute

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Jonathan A. Javitch, MD, PhD

Alla Landa, PhD, PRINCIPAL_INVESTIGATOR, New York State Psychiatric Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-14

Study Completion Date2024-08-27

Study Record Updates

Study Start Date2020-10-14

Study Completion Date2024-08-27

Terms related to this study

Additional Relevant MeSH Terms

Treatment Resistant Depression