Translational Neuroscience Optimization of GlyT1 Inhibitor (NCATS)
This study involves an interlinked design to determine the dose associated with optimal activity and occupancy of the Glyt1I PF-03463275 in healthy subjects and schizophrenia subjects and to test this dose in combination with cognitive remediation in the treatment of cognitive impairments of Schizophrenia.
Cognitive Impairments Associated With Schizophrenia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Translational Neuroscience Optimization of GlyT1 Inhibitor|
- Receptor Occupancy after administration of PF-03463275 using PET. [ Time Frame: Change from Baseline in Receptor Occupancy at 6 weeks ] [ Designated as safety issue: No ]To examine the receptor occupancy associated with PF-03463275.
- Alteration in Pre-Frontal Cortex function with PF-03463275 [ Time Frame: Change from Baseline in Pre-frontal Cortex Function at 6 weeks ] [ Designated as safety issue: No ]To test whether PF-03463275 alters Pre-Frontal Cortex function during a working memory task in a dose-related manner, as measured with fMRI.
- Efficacy of PF03463275 on cognitive measures in Schizophrenic subjects. [ Time Frame: Change from Baseline in cognitive measures at 5 weeks ] [ Designated as safety issue: No ]To test the efficacy of PF03463275 on Cognitive Test Performance in subjects with Schizophrenia
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: PF-03463275 Active Dose#1
Active Dose between 10 mg
Experimental: PF-03463275 Active Dose #2
Active dose between 20 mg
Experimental: PF-03463275 Active Dose #3
Active dose between 40mg
Placebo Comparator: Placebo
Placebo- no active dose of PF-03463275.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01911676
|Contact: Michelle Carbuto, BA||(203) firstname.lastname@example.org|
|United States, Connecticut|
|Connecticut Mental Health Center||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Michelle Carbuto, BA 203-376-3850 email@example.com|
|Principal Investigator: Deepak C D'Souza, MD|
|Principal Investigator:||Deepak C D'Souza, MD||Yale University|