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

Smoking Cessation research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Smoking Cessation

Schizophrenia

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Tropisetron10 mg/day

Drug:Placeboplacebo

Drug:Risperidone6mg/day

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

TropisetronTropisetron (10mg/day) + risperidone(6mg/day)

PlaceboPlacebo + risperidone (6mg/day)

Study Status

Completed

Start Date: November 2006

Completed Date: August 2011

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Thomas Kosten, MD

Lead Sponsor: Baylor College of Medicine

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT00435370

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