Completed

Tropisetron With Risperidone for Schizophrenia

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What is being tested

Tropisetron

+ Risperidone

+ Placebo

Drug
Who is being recruted

Behavior+3

+ Mental Disorders

+ Schizophrenia

From 18 to 64 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: November 2006
See protocol details

Summary

Principal SponsorBaylor College of Medicine
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2006

Actual date on which the first participant was enrolled.

Schizophrenia is a chronic and disabling brain disorder. People with schizophrenia may experience hallucinations, delusions, disordered thinking, movement disorders, social withdrawal, and cognitive deficits. In considering the high rate of cigarette smoking among people with schizophrenia, it is also likely that they smoke. People with schizophrenia who smoke tend to experience improved cognition, and tobacco withdrawal has been associated with deterioration of cognition. This suggests that nicotine may improve cognitive deficits or medication side effects in people with schizophrenia. Auditory sensory gating, a neural mechanism thought to reflect sensory information processing and affect cognition, is diminished in people with schizophrenia. Auditory sensory gating has been associated with the 7 nicotinic acetylcholine receptor, a brain receptor that is important for cognition and can be activated by nicotine. Activation of this receptor using an agonist medication, such as tropisetron, may produce the same positive effect that nicotine has on cognition. This study will determine the effectiveness of using tropisetron as supplemental therapy to the atypical neuroleptic risperidone in people with schizophrenia. Participants in this 12-week double blind study will be randomly assigned to receive either tropisetron or placebo. All participants will also follow a 6-mg risperidone regimen. Study visits will occur every 2 weeks throughout the study and final outcome assessments will include cognitive functioning and treatment safety and effectiveness.

Official TitleTropisetron With Risperidone for Schizophrenia
NCT00435370
Principal SponsorBaylor College of Medicine
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

179 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersSchizophreniaHealth BehaviorSmoking CessationSchizophrenia Spectrum and Other Psychotic Disorders

Criteria

5 inclusion criteria required to participate
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

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9 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Tropisetron (10mg/day) + risperidone(6mg/day)

Group II

Placebo
Placebo + risperidone (6mg/day)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Baylor College of Medicine - Michael E. DeBakey VA Medical Center

Houston, United StatesOpen Baylor College of Medicine - Michael E. DeBakey VA Medical Center in Google Maps
Suspended

Beijing Hui-Long Guan Hospital

Beijing, China
Completed2 Study Centers