A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
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.
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.
Inclusion Criteria:

 -  Medically healthy males or females aged 18-65 (inclusive).

 -  Patients must have a primary current diagnosis of MDD without psychotic features.

 -  Patients must be receiving ongoing antidepressant therapy at the time of screening.
 Duration of the current episode of MDD must be at least 8 weeks prior to enrollment
 without adequate response to treatment.

 Exclusion Criteria:

 -  Patients with other psychiatric disorders.

 -  Patients who use tobacco products.

 -  Alcohol or substance abuse or dependence.

 -  Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment.

 -  Pregnancy or breastfeeding.

 -  Clinically significant abnormalities on laboratory tests, electrocardiogram, or
 physical or neurologic examination.