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A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT01098240•Pfizer

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (58)

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

Key Dates

Start Date

June 14, 2010

Primary Completion Date

September 12, 2011

Completion Date

September 12, 2011

Last Updated

May 3, 2021

Enrollment

297

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

CP-601,927

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)