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
Overview
- Phase
- Phase 2
- Intervention
- CP-601,927
- Conditions
- Major Depressive Disorder
- Sponsor
- Pfizer
- Enrollment
- 297
- Locations
- 55
- Primary Endpoint
- Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Active Treatment
CP-601,927
Intervention: CP-601,927
Placebo
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
Time Frame: Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
MADRS measures the overall severity of depressive symptoms. The MADRS had a 10-item checklist. Items are rated on a scale of 0-6, for a total numeric range of scores from 0 (depressive symptoms absent) to 60 (numerically highest level of depressive symptoms).
Secondary Outcomes
- Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14(Weeks 8 (double-blind baseline) through 14)
- Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14(Week 8 (double-blind baseline) and weeks 9, 10, 12, 14)
- Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14(Weeks 8 (double-blind baseline), 11 and 14)
- Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13(Week 8 (double-blind baseline) and weeks 9 through 13)
- Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14(Weeks 8 (double-blind baseline) through 14)
- Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14(Weeks 8 (double-blind baseline) 9, 10, 12 and 14)
- Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14(Weeks 8 (double-blind baseline), 11 and 14)
- Number of Participants With Remission at Weeks 9, 10, 12 and 14(Weeks 9, 10, 12 and 14)
- Number of Participants With Response at Weeks 9 Through 14(Weeks 9 through 14)
- Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14(Weeks 8 (double-blind baseline), 11 and 14)
- Population Pharmacokinetics(Weeks 11,12 and 14)
- Plasma CP-601,927 Concentration(Week 11, 12 and 14)