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

NCT00435370 | Completed Phase 3 Results

• 1 other identifier: U01MH079639
• Study Type: interventional
• Target: 179
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Smoking Cessation; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tropisetron

EXPERIMENTAL

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

Drug: Tropisetron; Drug: Risperidone

Placebo

PLACEBO COMPARATOR

Placebo + risperidone (6mg/day)

Drug: Placebo; Drug: Risperidone

Interventions

Tropisetron DRUG

10 mg/day

Also known as: Navoban

Tropisetron

Placebo DRUG

placebo

Placebo

Risperidone DRUG

6mg/day

Also known as: Risperdal, Ridal, Rispolept

Placebo; Tropisetron

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

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

Houston, Texas, 77030, United States

Location

Beijing Hui-Long Guan Hospital

Beijing, China

Location

Related Publications (2)

• Yang M, Liu L, Cui H, Deng C, Xiong W, Zhao G, Du S, Kosten TR, Chen H, Li Z, Zhang X. Dynamic functional thalamocortical dysconnectivity in schizophrenia correlates to antipsychotics response. Schizophrenia (Heidelb). 2023 Jul 4;9(1):40. doi: 10.1038/s41537-023-00371-y.

  PMID: 37402747 DERIVED

• Zhang XY, Liu L, Liu S, Hong X, Chen DC, Xiu MH, Yang FD, Zhang Z, Zhang X, Kosten TA, Kosten TR. Short-term tropisetron treatment and cognitive and P50 auditory gating deficits in schizophrenia. Am J Psychiatry. 2012 Sep;169(9):974-81. doi: 10.1176/appi.ajp.2012.11081289.

  PMID: 22952075 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Schizophrenia

Interventions

Tropisetron; Risperidone

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Since all participants were the first episode and drug naive patients, some participants quit before the completion of the entire clinical trial

Results Point of Contact

• Title: Dr. Thomas R. Kosten
• Organization: Baylor College of Medicine

kosten@bcm.edu

(713) 794-7032

Study Officials

• Thomas Kosten, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2007
• First Posted: February 14, 2007
• Study Start: November 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 15, 2017
• Results First Posted: September 8, 2014

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); US (1)