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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01098240
First received: April 1, 2010
Last updated: December 21, 2011
Last verified: December 2011
History of Changes
  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:

U.S. FDA Resources

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

  Show 55 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 22, 2013