A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
NCT ID: NCT01098240
Last Updated: 2021-05-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
297 participants
INTERVENTIONAL
2010-06-14
2011-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active Treatment
CP-601,927
CP-601,927
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.
Placebo
Placebo
Placebo
Matching placebo tablets, taken orally, twice per day, for 6 weeks.
Interventions
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CP-601,927
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.
Placebo
Matching placebo tablets, taken orally, twice per day, for 6 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
Southwestern Research Incorporated
Beverly Hills, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Synergy Clinical Research Center
National City, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
William B. Backus Hospital Satellite Blood Draw
Norwich, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Florida Clinical Research Center, LLC
Maitland, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Atlanta Institute of Medicine and Research
Atlanta, Georgia, United States
AMR-Baber Research Inc.
Naperville, Illinois, United States
Psychiatric Medicine Associates, LLC.
Skokie, Illinois, United States
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, United States
Clinco
Terre Haute, Indiana, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Louisiana Research Associates, Inc.
New Orleans, Louisiana, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
AccelRx Research
Fall River, Massachusetts, United States
Detroit Bio-Medical Laboratories, Inc.
Rochester Hills, Michigan, United States
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, United States
Center for Emotional Fitness
Cherry Hill, New Jersey, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Erie County Medical Center / State University of New York at Buffalo affiliate
Buffalo, New York, United States
Comprehensive NeuroScience, Inc.
Fresh Meadows, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Kettlie Joseph Daniels, MD, Inc.
Toledo, Ohio, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States
IPS Research
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon), Inc.
Portland, Oregon, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
City Line Family Medicine
Bala-Cynwyd, Pennsylvania, United States
Suburban Research Associates
Media, Pennsylvania, United States
University of Pennsylvania / Department of Psychiatry
Philadelphia, Pennsylvania, United States
Frankford Avenue Family Practice, PC
Philadelphia, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Carolina Clinical Research Service LLC
Columbia, South Carolina, United States
FutureSearch Trials
Austin, Texas, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
University of Texas (UT) Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas (UT) Southwestern Medical Center at Dallas
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Radiant Research, Inc
Salt Lake City, Utah, United States
University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic
Salt Lake City, Utah, United States
University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences
Charlottesville, Virginia, United States
Mcguire Hall Annex
Richmond, Virginia, United States
Nelson Clinic
Richmond, Virginia, United States
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, United States
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3331017
Identifier Type: -
Identifier Source: org_study_id
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