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

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

297 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-14

Study Completion Date

2011-09-12

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active Treatment

CP-601,927

Group Type EXPERIMENTAL

CP-601,927

Intervention Type DRUG

CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Intervention Type DRUG

Placebo

Matching placebo tablets, taken orally, twice per day, for 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Southwestern Research Incorporated

Beverly Hills, California, United States

Site Status

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Site Status

Synergy Clinical Research Center

National City, California, United States

Site Status

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status

Radiant Research, Inc.

Denver, Colorado, United States

Site Status

Comprehensive Psychiatric Care

Norwich, Connecticut, United States

Site Status

William B. Backus Hospital Satellite Blood Draw

Norwich, Connecticut, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status

Florida Clinical Research Center, LLC

Maitland, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Comprehensive NeuroScience, Inc.

St. Petersburg, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Atlanta Institute of Medicine and Research

Atlanta, Georgia, United States

Site Status

AMR-Baber Research Inc.

Naperville, Illinois, United States

Site Status

Psychiatric Medicine Associates, LLC.

Skokie, Illinois, United States

Site Status

Goldpoint Clinical Research, LLC

Indianapolis, Indiana, United States

Site Status

Clinco

Terre Haute, Indiana, United States

Site Status

Heartland Research Associates, LLC

Wichita, Kansas, United States

Site Status

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

Site Status

Louisiana Research Associates, Inc.

New Orleans, Louisiana, United States

Site Status

Louisiana Clinical Research, LLC

Shreveport, Louisiana, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

AccelRx Research

Fall River, Massachusetts, United States

Site Status

Detroit Bio-Medical Laboratories, Inc.

Rochester Hills, Michigan, United States

Site Status

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Site Status

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, United States

Site Status

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Site Status

Social Psychiatry Research Institute

Brooklyn, New York, United States

Site Status

Erie County Medical Center / State University of New York at Buffalo affiliate

Buffalo, New York, United States

Site Status

Comprehensive NeuroScience, Inc.

Fresh Meadows, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Kettlie Joseph Daniels, MD, Inc.

Toledo, Ohio, United States

Site Status

Neurology and Neuroscience Center of Ohio

Toledo, Ohio, United States

Site Status

IPS Research

Oklahoma City, Oklahoma, United States

Site Status

Cutting Edge Research Group

Oklahoma City, Oklahoma, United States

Site Status

Summit Research Network (Oregon), Inc.

Portland, Oregon, United States

Site Status

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Site Status

City Line Family Medicine

Bala-Cynwyd, Pennsylvania, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

University of Pennsylvania / Department of Psychiatry

Philadelphia, Pennsylvania, United States

Site Status

Frankford Avenue Family Practice, PC

Philadelphia, Pennsylvania, United States

Site Status

Lincoln Research

Lincoln, Rhode Island, United States

Site Status

Carolina Clinical Research Service LLC

Columbia, South Carolina, United States

Site Status

FutureSearch Trials

Austin, Texas, United States

Site Status

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, United States

Site Status

University of Texas (UT) Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

University of Texas (UT) Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

InSite Clinical Research

DeSoto, Texas, United States

Site Status

Radiant Research, Inc

Salt Lake City, Utah, United States

Site Status

University of Utah School of Medicine Department of Psychiatry Mood Disorders Clinic

Salt Lake City, Utah, United States

Site Status

University of Virginia Health System / Department of Psychiatry and Neurobehavioral Sciences

Charlottesville, Virginia, United States

Site Status

Mcguire Hall Annex

Richmond, Virginia, United States

Site Status

Nelson Clinic

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University (VCU) Medical Center

Richmond, Virginia, United States

Site Status

Northbrooke Research Center

Brown Deer, Wisconsin, United States

Site Status

Dean Foundation for Health, Research and Education

Middleton, Wisconsin, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 25422883 (View on PubMed)

Related Links

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Other Identifiers

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A3331017

Identifier Type: -

Identifier Source: org_study_id

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