Status:
COMPLETED
Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Smoking Cessation
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE3
Brief Summary
This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive symptoms in Chinese people with schizophrenia.
Detailed Description
Schizophrenia is a chronic and disabling brain disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT00435370
Start Date
November 1 2006
End Date
August 1 2011
Last Update
March 15 2017
Active Locations (2)
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1
Baylor College of Medicine - Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
2
Beijing Hui-Long Guan Hospital
Beijing, China