A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00567203
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arms: 3
• Duration (Months): 6
• Patients Per Site: 18
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: PF-3463275; Drug: PF-3463275; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: PF-3463275; PF-3463275 10mg
Experimental: 2	Drug: PF-3463275; PF-3463275 25mg
Placebo Comparator: 3	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Change from baseline in the CNS Vital Signs Cognition Battery composite score [6 days]

2. Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's. [38 days]

3. Pharmacokinetics of PF-3463275 [6 days]

Secondary Outcome Measures

1. Positive and Negative Syndrome Scale (PANSS) [6 days]

2. Change from baseline in the CNS Vital Signs Cognition Battery domain scores [6 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Glendale	California	United States	91206
2	Pfizer Investigational Site	Willingboro	New Jersey	United States	08046

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00567203
• Other Study ID Numbers: A9131004
• First Posted: Dec 4, 2007
• Last Update Posted: Oct 2, 2008
• Last Verified: Oct 1, 2008

• Additional relevant MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction

Study Results

No Results Posted as of Oct 2, 2008