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

Schizophrenia Clinical Trial

Official title:

Tropisetron With Risperidone for Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435370
• Other study ID #: U01MH079639
• Secondary ID: U01MH079639
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2007
• Last updated: August 12, 2014
• Start date: November 2006
• Est. completion date: August 2011

Study information

• Verified date: August 2014
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: August 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia
• Smoking Cessation

Intervention

Drug:
• Tropisetron
10 mg/day
• Placebo
placebo
• Risperidone
6mg/day

Locations

Country	Name	City	State
China	Beijing Hui-Long Guan Hospital	Beijing
United States	Baylor College of Medicine - Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains	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™):	end of 12 wk treatment	No