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Phase 3 Completed N=179 Randomized Double-blind Treatment

Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia

Source: ClinicalTrials.gov NCT00435370 ↗
Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains — 96; 95 units on a scale — p=<0.05

Summary

This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive symptoms in Chinese people with schizophrenia.

Outcome Measures

OutcomeResultp-value
PRIMARY
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains
96; 95 <0.05 sig

Eligibility Criteria

Inclusion Criteria

  • Currently resides in Beijing, China
  • Diagnosis of schizophrenia or schizophreniform disorder
  • Duration of symptoms is no longer than 60 months
  • No history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
  • Current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the Brief Psychiatric Rating Scale (BPRS)

Exclusion Criteria

  • Diagnostic and Statistical Manual of Mental Disorders(DSM)-IV Axis I diagnosis other than schizophrenia or schizophreniform psychosis
  • Documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)
  • Acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
  • A clinically significant echocardiogram (ECG) abnormality in the opinion of the investigator
  • Pregnant or breastfeeding
  • Use of prohibited concomitant therapy
  • History of severe allergy or hypersensitivity
  • Dependence on alcohol or illegal drugs
  • Use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00435370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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