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

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ClinicalTrials.gov Identifier: NCT00435370
Recruitment Status : Completed
First Posted : February 14, 2007
Results First Posted : September 8, 2014
Last Update Posted : March 15, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine

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

Condition or disease Intervention/treatment Phase
Smoking Cessation Schizophrenia Drug: Tropisetron Drug: Placebo Drug: Risperidone Phase 3

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Tropisetron With Risperidone for Schizophrenia
Study Start Date : November 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Experimental: Tropisetron
Tropisetron (10mg/day) + risperidone(6mg/day)
Drug: Tropisetron
10 mg/day
Other Name: Navoban

Drug: Risperidone
Other Name: Risperdal, Ridal, Rispolept

Placebo Comparator: Placebo
Placebo + risperidone (6mg/day)
Drug: Placebo

Drug: Risperidone
Other Name: Risperdal, Ridal, Rispolept

Primary Outcome Measures :
  1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains [ Time Frame: end of 12 wk treatment ]

    The following 8 scales are combined into a single index that is normalized with a mean score of 100 and a standard deviation of 10. Higher scores are considered better cognitive performance. No subscales scores are reported and a final standardized score is reported as the average of the standardized scores on each of these scales. Here is the listing of component scales that were translated into Chinese and used for this study:

    Brief Assessment of Cognition in Schizophrenia (BACS): Symbol-Coding Trail Making Test: Part A Attention/Vigilance Continuous Performance Test-Identical Pairs (CPT-IP)* Wechsler Memory Scale®-3rd Ed. (WMS®-III): Spatial Span + Letter-Number Span Hopkins Verbal Learning Test-Revised™ (HVLT-R™) Brief Visuospatial Memory Test-Revised (BVMT-R™) Neuropsychological Assessment Battery® (NAB®): Mazes

    Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT™):

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435370

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United States, Texas
Baylor College of Medicine - Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
Beijing Hui-Long Guan Hospital
Beijing, China
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Mental Health (NIMH)
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Principal Investigator: Thomas Kosten, MD Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas R. Kosten, MD, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00435370    
Other Study ID Numbers: U01MH079639 ( U.S. NIH Grant/Contract )
U01MH079639 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2007    Key Record Dates
Results First Posted: September 8, 2014
Last Update Posted: March 15, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin 5-HT3 Receptor Antagonists