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A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
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
1 other identifier
interventional
297
1 country
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 major-depressive-disorder
Started Jun 2010
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedStudy Start
First participant enrolled
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2011
CompletedResults Posted
Study results publicly available
June 26, 2013
CompletedMay 3, 2021
April 1, 2021
1.2 years
April 1, 2010
September 18, 2012
April 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Double-blind Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score at Week 14
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).
Week 8 (double-blind baseline ) and week 14 (week 6 of double-blind phase)
Secondary Outcomes (12)
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 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 Bech Melancholia Subscale 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
- +7 more secondary outcomes
Other Outcomes (1)
The Sheehan Suicidality Tracking Scale (STS)
Week 8 (double-blind baseline) and weeks 9 through 14
Study Arms (2)
Active Treatment
EXPERIMENTALCP-601,927
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (58)
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223, United States
Southwestern Research Incorporated
Beverly Hills, California, 90210, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Synergy Clinical Research Center
National City, California, 91950, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
William B. Backus Hospital Satellite Blood Draw
Norwich, Connecticut, 06360, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Florida Clinical Research Center, LLC
Maitland, Florida, 32751, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30308, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, 30328, United States
AMR-Baber Research Inc.
Naperville, Illinois, 60563, United States
Psychiatric Medicine Associates, LLC.
Skokie, Illinois, 60076, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46260, United States
Clinco
Terre Haute, Indiana, 47802, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67207, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, 70114, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02171, United States
AccelRx Research
Fall River, Massachusetts, 02721, United States
Detroit Bio-Medical Laboratories, Inc.
Rochester Hills, Michigan, 48307, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63301, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Erie County Medical Center / State University of New York at Buffalo affiliate
Buffalo, New York, 14215, United States
Comprehensive NeuroScience, Inc.
Fresh Meadows, New York, 11366, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Kettlie Joseph Daniels, MD, Inc.
Toledo, Ohio, 43609, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
IPS Research
Oklahoma City, Oklahoma, 73103, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, 97210, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
City Line Family Medicine
Bala-Cynwyd, Pennsylvania, 19004, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
University of Pennsylvania / Department of Psychiatry
Philadelphia, Pennsylvania, 19104, United States
Frankford Avenue Family Practice, PC
Philadelphia, Pennsylvania, 19136, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Carolina Clinical Research Service LLC
Columbia, South Carolina, 29201, United States
FutureSearch Trials
Austin, Texas, 78731, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231, United States
University of Texas (UT) Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas (UT) Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9119, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
Radiant Research, Inc
Salt Lake City, Utah, 84107, United States
University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic
Salt Lake City, Utah, 84132, United States
University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, 22903, United States
Mcguire Hall Annex
Richmond, Virginia, 23219, United States
Nelson Clinic
Richmond, Virginia, 23219, United States
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, 23298-0155, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, United States
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, 53562, United States
Related Publications (1)
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.
PMID: 25422883DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2010
First Posted
April 2, 2010
Study Start
June 14, 2010
Primary Completion
September 12, 2011
Study Completion
September 12, 2011
Last Updated
May 3, 2021
Results First Posted
June 26, 2013
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.