A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: PF-3463275

• Registration Number: NCT00567203
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-12-03
• Study First Submitted QC: 2007-12-03
• Study First Posted: 2007-12-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-01
• Last Update Posted: 2008-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

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Exclusion Criteria

• Subjects with a psychiatric disorder other than schizophrenia
• Substance dependence or abuse
• Women who have child bearing potential.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
1	PF-3463275	-
2	PF-3463275	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the CNS Vital Signs Cognition Battery composite score	6 days
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.	38 days
Pharmacokinetics of PF-3463275	6 days

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the CNS Vital Signs Cognition Battery domain scores	6 days
Positive and Negative Syndrome Scale (PANSS)	6 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Willingboro, New Jersey, United States