A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT01098240
- Run by
- Pfizer
- People needed
- 297
- Starts
- 2010-06-14
- Expected to finish
- 2011-09-12
- Last updated by the study team
- 2021-05-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- 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
- Arkansas Psychiatric Clinic Clinical Research Trials, P.A. — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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