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
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
Icahn School of Medicine at Mount Sinai Stony Brook University