Conditions: Major Depressive Disorder
Keywords: Antidepressant Augmentation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 297
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: CP-601,927 arm 2: Placebo

Interventions: intervention 1: CP-601,927 intervention 2: Placebo
Intervention descriptions: intervention 1: CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks. intervention 2: Matching placebo tablets, taken orally, twice per day, for 6 weeks.

Protocol document: