Clinical trial NCT01098240: A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Antidepressant Augmentation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
timeFrame: Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
Secondary outcomes:
measure: Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Weeks 9 Through 13
timeFrame: Week 8 (double-blind baseline) and weeks 9 through 13
measure: Change From Double-blind Baseline in Hamilton Depression Scale 25-item (HAM-D25) - Total Score at Weeks 9 Through 14
timeFrame: Weeks 8 (double-blind baseline) through 14
measure: Change From Double-blind Baseline in Bech Melancholia Subscale Score at Weeks 9 Through 14
timeFrame: Weeks 8 (double-blind baseline) through 14
measure: Change From Double-blind Baseline in Clinical Global Impression - Severity (CGI-S) at Weeks 9, 10, 12, and 14
timeFrame: Week 8 (double-blind baseline) and weeks 9, 10, 12, 14
measure: Change From Double-blind Baseline in Sheehan Irritability Scale (SIS) Total Score at Weeks 11 and 14
timeFrame: Weeks 8 (double-blind baseline), 11 and 14
measure: Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Total Score at Weeks 11 and 14
timeFrame: Weeks 8 (double-blind baseline), 11 and 14
measure: Change From Double-blind Baseline in Sheehan Disability Scale (SDS) Subscale Score at Weeks 11 and 14
timeFrame: Weeks 8 (double-blind baseline), 11 and 14
measure: Clinical Global Impression - Improvement (CGI-I) Total Score at Weeks 9, 10, 12 and 14
timeFrame: Weeks 8 (double-blind baseline) 9, 10, 12 and 14
measure: Number of Participants With Remission at Weeks 9, 10, 12 and 14
timeFrame: Weeks 9, 10, 12 and 14
measure: Number of Participants With Response at Weeks 9 Through 14
timeFrame: Weeks 9 through 14
measure: Population Pharmacokinetics
timeFrame: Weeks 11,12 and 14
measure: Plasma CP-601,927 Concentration
timeFrame: Week 11, 12 and 14
Other outcomes:
measure: The Sheehan Suicidality Tracking Scale (STS)
timeFrame: Week 8 (double-blind baseline) and weeks 9 through 14
Locations:
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Beverly Hills
country: United States
facility: Southwestern Research Incorporated
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Norwich
country: United States
facility: William B. Backus Hospital Satellite Blood Draw
state: Connecticut
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Maitland
country: United States
facility: Florida Clinical Research Center, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive NeuroScience, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Institute of Medicine and Research
state: Georgia
city: Naperville
country: United States
facility: AMR-Baber Research Inc.
state: Illinois
city: Skokie
country: United States
facility: Psychiatric Medicine Associates, LLC.
state: Illinois
city: Indianapolis
country: United States
facility: Goldpoint Clinical Research, LLC
state: Indiana
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Clinical Research, LLC
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Fall River
country: United States
facility: AccelRx Research
state: Massachusetts
city: Rochester Hills
country: United States
facility: Detroit Bio-Medical Laboratories, Inc.
state: Michigan
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group
state: Missouri
city: Cherry Hill
country: United States
facility: Center for Emotional Fitness
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center / State University of New York at Buffalo affiliate
state: New York
city: Fresh Meadows
country: United States
facility: Comprehensive NeuroScience, Inc.
state: New York
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Toledo
country: United States
facility: Kettlie Joseph Daniels, MD, Inc.
state: Ohio
city: Toledo
country: United States
facility: Neurology and Neuroscience Center of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: Cutting Edge Research Group
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (Oregon), Inc.
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: City Line Family Medicine
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania / Department of Psychiatry
state: Pennsylvania
city: Philadelphia
country: United States
facility: Frankford Avenue Family Practice, PC
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Columbia
country: United States
facility: Carolina Clinical Research Service LLC
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, L.P.
state: Texas
city: Dallas
country: United States
facility: University of Texas (UT) Southwestern Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas (UT) Southwestern Medical Center at Dallas
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research, Inc
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences
state: Virginia
city: Richmond
country: United States
facility: Mcguire Hall Annex
state: Virginia
city: Richmond
country: United States
facility: Nelson Clinic
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU) Medical Center
state: Virginia
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
city: Middleton
country: United States
facility: Dean Foundation for Health, Research and Education
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Fava M, Ramey T, Pickering E, Kinrys G, Boyer S, Altstiel L. A randomized, double-blind, placebo-controlled phase 2 study of the augmentation of a nicotinic acetylcholine receptor partial agonist in depression: is there a relationship to leptin levels? J Clin Psychopharmacol. 2015 Feb;35(1):51-6. doi: 10.1097/JCP.0000000000000245.