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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174200
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 15, 2008
Information provided by:

September 9, 2005
September 15, 2005
July 15, 2008
December 2004
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Change from baseline on Day 8 and change from baseline on Day 15 in performance of the GMLT and MDR tasks.
Same as current
Complete list of historical versions of study NCT00174200 on Archive Site
  • 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
Additional descriptive analyses will be done using the change from baseline in Extrapyramidal Symptoms Rating Score - Abbreviated (ESRS-A), the Positive and Negative Syndrome Scale (PANSS), Social and Occupational Functioning Assessment Scale (SOFAS), a
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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.
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
Drug: Risperidone 2 mg
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2006
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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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   Russian Federation
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Study Director: Pfizer Call Center Pfizer
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP