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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thomas R. Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00435370
First received: February 13, 2007
Last updated: August 12, 2014
Last verified: August 2014

February 13, 2007
August 12, 2014
November 2006
February 2011   (final data collection date for primary outcome measure)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Domains [ Time Frame: end of 12 wk treatment ] [ Designated as safety issue: No ]

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™):

  • Cognitive deficits as assessed by tests measuring the MATRICS cognition domains
  • Negative schizophrenic symptoms
  • Reduction in the side effects of risperidone
  • Abnormality in P50 inhibition
  • Nicotine use among the participants who smoke (all measured at Week 12)
Complete list of historical versions of study NCT00435370 on ClinicalTrials.gov Archive Site
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Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia
Tropisetron With Risperidone for Schizophrenia

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Smoking Cessation
  • Schizophrenia
  • Drug: Tropisetron
    10 mg/day
    Other Name: Navoban
  • Drug: Placebo
    placebo
  • Drug: Risperidone
    6mg/day
    Other Name: Risperdal, Ridal, Rispolept
  • Experimental: Tropisetron
    Tropisetron (10mg/day) + risperidone(6mg/day)
    Interventions:
    • Drug: Tropisetron
    • Drug: Risperidone
  • Placebo Comparator: Placebo
    Placebo + risperidone (6mg/day)
    Interventions:
    • Drug: Placebo
    • Drug: Risperidone
Zhang XY, Liu L, Liu S, Hong X, Chen da C, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
August 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   China
 
NCT00435370
U01 MH079639, U01MH079639
No
Thomas R. Kosten, MD, Baylor College of Medicine
Baylor College of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Thomas Kosten, MD Baylor College of Medicine
Baylor College of Medicine
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP