Study To Assess Differential Sensitivity Of 2 Spatial Working Memory Tests In Schizophrenics Treated With Risperidone

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

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.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Schizophrenia
• Intervention / Treatment: Drug: Risperidone 2 mg

• Study Type: Interventional
• Enrollment: 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada, B2Y 3Z9
      • Pfizer Investigational Site
    • Halifax, Nova Scotia, Canada, B3H 2E2
      • Pfizer Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 107076
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Study Completion (Actual): May 1, 2006

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): July 15, 2008
• Last Update Submitted That Met QC Criteria: July 11, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: A9001229