Back to resultsStudy To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
Primary Purpose
Schizophrenia, Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Risperidone 2 mg
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Male or female, 18 to 50 years old, antipsychotic-naive, non-agitated patients diagnosed with first-episode schizophrenia or schizophreniform disorder. Exclusion Criteria: Evidence or history of clinically significant medical or non-medical impairment that, in the opinion of the investigator, would affect the safety of the patient or interfere with the evaluation of the trial results; Patients who have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug on the Screening urine toxicology test Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks.
Secondary Outcome Measures
Additional descriptive analyses: Change from baseline in ESRS, PANSS, SOFAS, SRDEQ, and AVM on D8+15; CGI-C on D8+15
-Change from baseline in GMLT, ODR, ESRS, PANSS, SOFAS, SRDEQ, AVM on D43; CGI-C on D43
-ESRS will also be performed on D4+11
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174200
Brief Title
Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
Official Title
A Randomized, Double-Blind, Crossover Add-On Study To Assess The Differential Sensitivity Of 2 Spatial Working Memory Tests (The Groton Maze Learning Test [GMLT] And The Motor Delayed Response Test [MDR]) In Non-Agitated, Antipsychotic Drug-Naive First-Episode Schizophrenic Or Schizophreniform Patients Treated With Risperidone 2 Mg Daily Or Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
To assess the effect of risperidone 2 mg daily (QD) on the differential sensitivity of 2 spatial working memory tests (the GMLT and MDR) in non-agitated, drug-naive patients suffering from first-episode schizophrenia/schizophreniform disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Risperidone 2 mg
Primary Outcome Measure Information:
Title
Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks.
Secondary Outcome Measure Information:
Title
Additional descriptive analyses: Change from baseline in ESRS, PANSS, SOFAS, SRDEQ, and AVM on D8+15; CGI-C on D8+15
Title
-Change from baseline in GMLT, ODR, ESRS, PANSS, SOFAS, SRDEQ, AVM on D43; CGI-C on D43
Title
-ESRS will also be performed on D4+11
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 18 to 50 years old, antipsychotic-naive, non-agitated patients diagnosed with first-episode schizophrenia or schizophreniform disorder.
Exclusion Criteria:
Evidence or history of clinically significant medical or non-medical impairment that, in the opinion of the investigator, would affect the safety of the patient or interfere with the evaluation of the trial results;
Patients who have a history of substance (which included alcohol) dependence within 12 months or abuse within 3 months of enrollment, or tested positive for an illicit drug on the Screening urine toxicology test
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
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
Dartmouth
State/Province
Nova Scotia
ZIP/Postal Code
B2Y 3Z9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9001229&StudyName=Study%20To%20Assess%20Differential%20Sensitivity%20Of%202%20Spatial%20Working%20Memory%20Tests%20In%20Schizophrenics%20Treated%20With%20Risperidone
Description
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Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
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