Add On Treatment for Cognitive Deficits in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT01346163|
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : May 2, 2011
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: PF 03654746 Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase1B Study: A Placebo Controlled Study of PF-03654746 Given as Add-On Treatment of Cognitive Deficits in Schizophrenia|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Active Comparator: PF-03654746
H3 receptor antagonist currently being developed for the treatment of cognitive impairment associated with schizophrenia (CIAS) as well as with Alzheimer's disease.
Drug: PF 03654746
All participants will receive 3 weeks of PF-03654746 and 3 weeks of placebo. PF-03654746 and placebo will be administered in a flexible titration regimen, beginning with 0.5 mg/d. If 0.5 mg/d is well tolerated, the dose will be increased to 1.0 mg/d after 5 days. If 1.0 mg/d is not well tolerated, the dose will be decreased to 0.5 mg/d, with the goal of achieving a stable dose of PF-03654746 within the first two weeks of dosing and avoiding further dose changes during the final week of dosing.
|Placebo Comparator: Placebo||
Placebo will be used as a comparator to the active arm.
- MATRICS Consensus Cognitive Battery [ Time Frame: 13 - 15 Weeks ]
- ASL perfusion and performance on neurocognitive measures [ Time Frame: 3 Weeks ]
- fMRI activation parameters and performance on neurocognitive measures. [ Time Frame: 3 weeks ]
- ERP measures and performance on neurocognitive measures [ Time Frame: 3 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346163
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Raquel P. Gur, M.D., Ph.D.||University of Pennsylvania|