NCT00567203
Completed
Phase 1
A Phase 1B Inpatient, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-3463275 In Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- PF-3463275
- Conditions
- Schizophrenia
- Sponsor
- Pfizer
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change from baseline in the CNS Vital Signs Cognition Battery composite score
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of schizophrenia
- •In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months
- •Stable symptoms of schizophrenia for at least 3 months.
Exclusion Criteria
- •Subjects with a psychiatric disorder other than schizophrenia
- •Substance dependence or abuse
- •Women who have child bearing potential.
Arms & Interventions
1
Intervention: PF-3463275
2
Intervention: PF-3463275
3
Intervention: Placebo
Outcomes
Primary Outcomes
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Time Frame: 6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Time Frame: 38 days
Pharmacokinetics of PF-3463275
Time Frame: 6 days
Secondary Outcomes
- Positive and Negative Syndrome Scale (PANSS)(6 days)
- Change from baseline in the CNS Vital Signs Cognition Battery domain scores(6 days)
Study Sites (1)
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