A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized Phase 2a, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression|
- Change from double blind baseline in MADRS total score at Week 14 (after 6 weeks of double blind therapy). [ Time Frame: Week 14 - Week 8 ] [ Designated as safety issue: No ]
- Vital signs, ECG, adverse events, physical examination findings, safety laboratory assessments, STS score. [ Time Frame: Weeks 8, 9, 10, 11, 12, 13, 14 ] [ Designated as safety issue: Yes ]
- Change from double blind baseline at Weeks 9-14 in HAM D25 total score, Bech Melancholia subscale score; at Weeks 9, 10, 12, and 14 in CGI-S score; and at Weeks 11 and 14 in SDS score. [ Time Frame: Week 9-14 ] [ Designated as safety issue: No ]
- Change from double-blind baseline at Weeks 9-13 in MADRS total score. [ Time Frame: Week 9-13 ] [ Designated as safety issue: No ]
- Total CGI-I score at Weeks 9, 10, 12, and 14. [ Time Frame: Week 9, 10, 12, 13, 14 ] [ Designated as safety issue: No ]
- Response rates, defined as >50% reduction from double-blind baseline in MADRS total score, at Weeks 9-14. [ Time Frame: Week 9-14 ] [ Designated as safety issue: No ]
- Remission rates, defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI I score <2 ("much" or "very much" improved), at Weeks 9, 10, 12, and 14. [ Time Frame: Week 9, 10, 12, 14 ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Study Completion Date:||September 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Experimental: Active Treatment
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.
Placebo Comparator: Placebo
Matching placebo tablets, taken orally, twice per day, for 6 weeks.
The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns regarding subject safety.
Show 55 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|