A Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00977522
First received: September 14, 2009
Last updated: February 2, 2012
Last verified: February 2012
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Purpose
This study is examining the efficacy of PF-03463275 compared to placebo in treating negative symptoms of schizophrenia when added to ongoing antipsychotic treatment in stable outpatients with schizophrenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: PF-03463275 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized Phase 2, Double-Blind, Placebo-Controlled, Multi-Center Study Of PF-03463275 As Add-On Therapy In Outpatients With Persistent Negative Symptoms Of Schizophrenia Treated With A Stable Dose Of A Second Generation Antipsychotic |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) Negative Subscale score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Vital Signs (Blood pressure, heart rate) [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
- ECG [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
- Safety laboratory assessments [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from baseline in Quality of Life Scale (QLS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in MATRICS Composite Cognition Battery (MCCB) composite and individual cognition domain scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in PANSS Total [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in PANSS Positive Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in PANSS General Subscale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Clinical Global Impression Severity (CGI-S) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Clinical Global Impression Improvement (CGI-I) Total Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Scale for Assessment of Negative Symptoms (SANS), modified [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Abbreviated Extrapyramidal Symptom Rating Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in Global Assessment of Functioning [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 15 weeks ] [ Designated as safety issue: Yes ]
- Pharmacokinetic assays [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 207 |
| Study Start Date: | November 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-03463275 |
Drug: PF-03463275
30 mg Controlled Release tablet BID for 12 weeks
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo tablet BID
|
Detailed Description:
The study was terminated on August 25, 2010 because the study's scientific validity could no longer be supported. The decision to terminate the trial was not based on any safety concerns.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype in the residual phase.
- Subjects must be in ongoing maintenance antipsychotic monotherapy with risperidone, olanzapine, quetiapine, ziprasidone, paliperidone, or aripiprazole. Subjects must be on a stable medication treatment regimen for at least 2 months.
- Evidence of stable symptomatology at least 3 months.
Exclusion Criteria:
- Female subjects who are pregnant or breastfeeding.
- Subjects with evidence or history of a clinically significant medical condition which would increase risk or which could interfere with the interpretation of trial results.
- Subjects who have DSM IV defined psychoactive substance dependence (including alcohol and excluding nicotine and caffeine dependence) within 12 months of screening or substance abuse within 3 months prior to screening.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977522
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Hide Study LocationsLocations
| United States, California | |
| Pfizer Investigational Site | |
| Cerritos, California, United States, 90703 | |
| Pfizer Investigational Site | |
| Chula Vista, California, United States, 91910 | |
| Pfizer Investigational Site | |
| Escondido, California, United States, 92025 | |
| Pfizer Investigational Site | |
| Garden Grove, California, United States, 92845 | |
| Pfizer Investigational Site | |
| Glendale, California, United States, 91436 | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90805 | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90808 | |
| Pfizer Investigational Site | |
| National City, California, United States, 91950 | |
| Pfizer Investigational Site | |
| Paramount, California, United States, 90723 | |
| Pfizer Investigational Site | |
| Torrance, California, United States, 90502 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20016 | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20036 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30328 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30308 | |
| Pfizer Investigational Site | |
| Decatur, Georgia, United States, 30333 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Park Ridge, Illinois, United States, 60068 | |
| United States, Kansas | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67207 | |
| Pfizer Investigational Site | |
| Wichita, Kansas, United States, 67211 | |
| United States, Mississippi | |
| Pfizer Investigational Site | |
| Flowood, Mississippi, United States, 39232 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89102 | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89128 | |
| United States, New Jersey | |
| Pfizer Investigational Site | |
| Runnemede, New Jersey, United States, 08078 | |
| Pfizer Investigational Site | |
| Toms River, New Jersey, United States, 08755 | |
| Pfizer Investigational Site | |
| Willingboro, New Jersey, United States, 08046 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Fresh Meadows, New York, United States, 11366 | |
| Pfizer Investigational Site | |
| Holliswood, New York, United States, 11423 | |
| Pfizer Investigational Site | |
| Staten Island, New York, United States, 10304 | |
| Pfizer Investigational Site | |
| Staten Island, New York, United States, 10305 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Edmond, Oklahoma, United States, 73034 | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73116 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19139 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78754 | |
| Pfizer Investigational Site | |
| Austin, Texas, United States, 78731 | |
| Pfizer Investigational Site | |
| Bellaire, Texas, United States, 77401 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77008 | |
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: | NCT00977522 History of Changes |
| Other Study ID Numbers: | A9131005 |
| Study First Received: | September 14, 2009 |
| Last Updated: | February 2, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
schizophrenia negative symptoms adjunctive |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013