A Study Of The Efficacy And Safety Of CP-601,927 Augmentation Of Antidepressant Therapy In Major Depression
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01098240
First received: April 1, 2010
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: CP-601,927 Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from double blind baseline in MADRS total score at Week 14 (after 6 weeks of double blind therapy). [ Time Frame: Week 14 - Week 8 ] [ Designated as safety issue: No ]
- Vital signs, ECG, adverse events, physical examination findings, safety laboratory assessments, STS score. [ Time Frame: Weeks 8, 9, 10, 11, 12, 13, 14 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from double blind baseline at Weeks 9-14 in HAM D25 total score, Bech Melancholia subscale score; at Weeks 9, 10, 12, and 14 in CGI-S score; and at Weeks 11 and 14 in SDS score. [ Time Frame: Week 9-14 ] [ Designated as safety issue: No ]
- Change from double-blind baseline at Weeks 9-13 in MADRS total score. [ Time Frame: Week 9-13 ] [ Designated as safety issue: No ]
- Total CGI-I score at Weeks 9, 10, 12, and 14. [ Time Frame: Week 9, 10, 12, 13, 14 ] [ Designated as safety issue: No ]
- Response rates, defined as >50% reduction from double-blind baseline in MADRS total score, at Weeks 9-14. [ Time Frame: Week 9-14 ] [ Designated as safety issue: No ]
- Remission rates, defined as response plus an absolute MADRS total score of less than or equal to 10 plus a CGI I score <2 ("much" or "very much" improved), at Weeks 9, 10, 12, and 14. [ Time Frame: Week 9, 10, 12, 14 ] [ Designated as safety issue: No ]
| Enrollment: | 162 |
| Study Start Date: | June 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Active Treatment
CP-601,927
|
Drug: CP-601,927
CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.
|
|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Matching placebo tablets, taken orally, twice per day, for 6 weeks.
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098240
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| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72223 | |
| United States, California | |
| Pfizer Investigational Site | |
| Beverly Hills, California, United States, 90210 | |
| Pfizer Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| Pfizer Investigational Site | |
| National City, California, United States, 91950 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Pfizer Investigational Site | |
| Denver, Colorado, United States, 80239 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Norwich, Connecticut, United States, 06360 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| Pfizer Investigational Site | |
| Maitland, Florida, United States, 32751 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33716 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30328 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Naperville, Illinois, United States, 60563 | |
| Pfizer Investigational Site | |
| Skokie, Illinois, United States, 60076 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| Pfizer Investigational Site | |
| Terre Haute, Indiana, United States, 47802 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Lake Charles, Louisiana, United States, 70629 | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70114 | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71115 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Boston, Massachusetts, United States, 02171 | |
| Pfizer Investigational Site | |
| Fall River, Massachusetts, United States, 02721 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Rochester Hills, Michigan, United States, 48307 | |
| United States, Missouri | |
| Pfizer Investigational Site | |
| St. Charles, Missouri, United States, 63301 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Cherry Hill, New Jersey, United States, 08002 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Bronx, New York, United States, 10467 | |
| Pfizer Investigational Site | |
| Brooklyn, New York, United States, 11235 | |
| Pfizer Investigational Site | |
| Buffalo, New York, United States, 14215 | |
| Pfizer Investigational Site | |
| Fresh Meadows, New York, United States, 11366 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45417 | |
| Pfizer Investigational Site | |
| Toledo, Ohio, United States, 43623 | |
| Pfizer Investigational Site | |
| Toledo, Ohio, United States, 43609 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Allentown, Pennsylvania, United States, 18103 | |
| Pfizer Investigational Site | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| Pfizer Investigational Site | |
| Media, Pennsylvania, United States, 19063 | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19136 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78731 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390-9119 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| Pfizer Investigational Site | |
| DeSoto, Texas, United States, 75115 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84132 | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Charlottesville, Virginia, United States, 22903 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23219 | |
| Pfizer Investigational Site | |
| Richmond, Virginia, United States, 23298-0155 | |
| United States, Wisconsin | |
| Pfizer Investigational Site | |
| Brown Deer, Wisconsin, United States, 53223 | |
| Pfizer Investigational Site | |
| Middleton, Wisconsin, United States, 53562 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01098240 History of Changes |
| Other Study ID Numbers: | A3331017 |
| Study First Received: | April 1, 2010 |
| Last Updated: | December 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Antidepressant Augmentation |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013