Back to resultsA Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-3463275
PF-3463275
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Pharmacokinetics of PF-3463275
Secondary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00567203
Brief Title
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
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 Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-3463275
Intervention Description
PF-3463275 10mg
Intervention Type
Drug
Intervention Name(s)
PF-3463275
Intervention Description
PF-3463275 25mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in the CNS Vital Signs Cognition Battery composite score
Time Frame
6 days
Title
Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's.
Time Frame
38 days
Title
Pharmacokinetics of PF-3463275
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
6 days
Title
Change from baseline in the CNS Vital Signs Cognition Battery domain scores
Time Frame
6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pfizer Investigational Site
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9131004&StudyName=A%20Study%20Of%20Adjunctive%20Treatment%20Of%20Cognitive%20Deficits%20In%20Schizophrenia
Description
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Learn more about this trial
A Study Of Adjunctive Treatment Of Cognitive Deficits In Schizophrenia
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