Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone
Not Applicable
Completed
- Conditions
- Psychotic DisordersSchizophrenia
- Registration Number
- NCT00174200
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇷🇺Moscow, Russian Federation