Response and safety of BMS-820836 in patients with major depression
Research type
Research Study
Full title
A Multicenter, Randomized, Double-blind, Active-Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients with Treatment Resistant Major Depression
IRAS ID
88564
Contact name
Gary Sullivan
Sponsor organisation
Bristol-Myers Squibb
Eudract number
2011-000778-71
Clinicaltrials.gov Identifier
Research summary
For many patients, current anti-depressive treatments alleviate some of their symptoms of depression. BMS-820836 is being evaluated for its ability to target all the symptoms of depression with reduced side effects by blocking the uptake of all 3 brain transmitters involved.The study aims to establish the most effective dose of BMS-820836 by assessing the alleviation of symptoms and the side effects of the drug at different doses and comparing these to 2 drugs already approved for the treatment of depression.After patients are consented into the study, their level of depression will be assessed using different interview based questions and self administered questionnaires, some of which may be taped. Their current anti-depressive medication will then be tapered off before they are randomized into the second phase of the study. In phase B they will receive either duloxetine or escitalopram for 7 weeks. At the end of 7 weeks if they still meet the pre determined levels of depression they will be randomized onto phase C of the study where they will receive one of 4 different doses of BMS-820836 or the control drug, either duloxetine or escitalopram. They will receive the allocated medication for 6 weeks. At the end of the 6 weeks they can either wash out of the medication and finish the study or enter a further study which will further assess BMS-820836 over an extended 54 week period.During the study alongside the interviews and questionnaires at each visit, patients will 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 an electrocardiogram (ECG) every 7 weeks. The study is sponsored by Bristol-Myers Squibb and patients will be recruited from primary and secondary care.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
11/WM/0306
Date of REC Opinion
1 Nov 2011
REC opinion
Further Information Favourable Opinion