Safety & tolerability of BMS-820836 in patients with major depression
Research type
Research Study
Full title
A Multicenter, Double-blind, 58 week Rollover Study to assess the Safety and Tolerability of BMS-820836 in Patients with Treatment Resistant Major Depression
IRAS ID
88937
Contact name
Gary Sullivan
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2010-024371-12
Clinicaltrials.gov Identifier
Research summary
For many patients, current anti-depressive treatments alleviate some but not all of the symptoms of depression. BMS-820836 is an intestigational treatment that's being evaluated for its ability to target all the symptoms with reduced side effects by blocking the uptake of all 3 brain transmitters involved in depression.The study aims to establish the most effective dose of BMS-820836 by assessing the side effects and tolerability of the drug at different doses over an extended period of 54 weeks.Patients must first have completed the CN162-007 study. After the end of the randomized phase of the parent study if they wish to, they will be consented onto this study without a washout period. Each patient will be assigned to one of 3 dose groups of BMS-820836 dependant on which dose they received in the parent 007 study. Those who received duloxetine or escitalopram will be randomised to receive one of the three doses of BMS-820836. They will stay on this dose for 54 weeks and their symptoms of depression and any side effects followed. After 54 weeks the treatment will be stopped and patients will be followed for 4 weeks to assess side effects.During the study patients will be assessed for their level of depression using clinician administered interviews and self-administered questionnaires at each visit. Patients will also undergo physical examinations, weight and vital signs, and have blood samples taken at all study visits. Patients will have urine taken at some visits, and will have 7 electrocardiograms (ECG) during the study. The study is sponsored by Bristol-Myers Squibb and patients will be recruited from primary and secondary care having first completed the parent CN162-007 study.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
11/WM/0307
Date of REC Opinion
1 Nov 2011
REC opinion
Further Information Favourable Opinion