Health Condition 1: null- Patients with Treatment Resistant Major Depression
Conditions
Interventions
Intervention1: BMS-820836: 0.25 mg, 0.5 mg , 1.0 mg , 2.0 mg DOSE,
Once a Day , 6 weeks, per oral route
Control Intervention1: Esctalopram or Duloxetine: 20 mg or 60 mg , 13 weeks , Once a day , per
Sponsors
BRISTOL MYERS SQUIBB
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use; 2) Subjects with a diagnosis of Major depressive disorder , currently experiencing a Major Depressive Episode, as defined by DSM IV TR criteria. The current depressive episode must be > 8 weeks in duration and 3) In the current MDD episode, subjects should report a history of inadequate response to 1 - 3 adequate trials of antidepressant treatment. a) An inadequate response is defined as a by the subject in the ATRQ. b) An adequate trial is defined as antidepressant treatment for an adequate duration (ie, >= 6 weeks for monotherapy and >= at least 3 weeks for combination treatments) and at an adequate dose (ie, as specified in the ATRQ). 4) If there is a history of a > 50% reduction in depressive symptoms on the ATRQ, it may be possible for a subject to enter the study provided they meet either of the 2 conditions below: a) Although there was a > 50% improvement to a previous antidepressant trial for the current episode, this response did not endure (ie, adequate trial of antidepressant treatment was documented within the period in question; or b) Although there was a > 50% improvement to a previous antidepressant trial for the current episode, despite the improvement the subject still met the diagnostic criteria for MDD AND subsequently inadequate response to an adequate trial of antidepressant treatment was documented. 5) Subjects must have a 17-item Hamilton Depression Rating Scale (HAM-D17) Total score >= 18 at Screening; Additional inclusion criteria to be assessed at the end of Phase B (Week 8 visit) for Randomization into Phase C: 1) Subjects must have a HAM-D17 Total score of >= 16 at Week 7 of Phase B and; 2) Subjects must have a HAM-D17 Total score that represents 3) Subjects must have a CGI-Improvement score of >= 3 at Week 5 and Week 7 of Phase B. 4) Subjects must have failed 2 different classes of antidepressant medication (adequate dose and duration)during the current episode (including Phase B treatment) 5) Subjects, 18-65 years , able to give informed consent , and / or consent obtained from LAR ( as required by IRB)
Exclusion criteria
Exclusion criteria: 1) Subjects with inadequate response ( 50% reduction in depressive symptom severity) to more than 3 adequate trials of antidepressant treatments during the current depressive episode (relevant antidepressant treatments include monotherapy and distinct combination regimens) at a therapeutic dose (as defined by the ATRQ) and for an adequate duration (minimum duration of 6 weeks for any monotherapy and 3 weeks for any combination regimen); 2) Subjects who have previously failed to respond to duloxetine and escitalopram treatment at an adequate dose and for an adequate duration in their current Major Depressive Episode unless, in the judgment of the investigator, the subject could benefit from treatment with one of these medications. 3) Benzodiazepine use within 1 week prior to enrollment into Phase B (Baseline Visit) unless subjects have received a stable dose for >= 2 weeks prior to enrollment and will continue to receive the same stable regimen through Phase B and C of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to summarize the burden of disease, the utility score and VAS score of the EQD will be summarized at the End of Phase B using descriptive summary statistics and correlated with the MADRS score, the duration of the current episode, and with the number of previous antidepressant treatment failures.Timepoint: baseline , 7th Week , 13 the Week , 21st Week , 24th Week | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint is the change from end of Phase B (Week 7) to end of Phase C (Week 13) in the SDS Mean score. This endpoint will be evaluated using MMRM analyses with a model similar to the model used for the primary efficacy measure.Timepoint: basline , 7thy Week , 13th week , 21st week , 24th week | — |
Countries
Australia, Brazil, Canada, India, Turkey, United Kingdom, United States of America
Contacts
Public ContactMrs Subashri Shivkumar
Outcome results
None listed