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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Institute of Mental Health (NIMH).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00435370
First received: February 13, 2007
Last updated: March 12, 2009
Last verified: March 2009

February 13, 2007
March 12, 2009
November 2006
March 2010   (final data collection date for primary outcome measure)
Cognitive deficits as assessed by tests measuring the MATRICS cognition domains [ Time Frame: Baseline, end of 12 wk treatment ] [ Designated as safety issue: No ]
  • 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
  • Negative schizophrenic symptoms [ Time Frame: Screening, baseline, every 2 weeks after for duration of study ] [ Designated as safety issue: No ]
  • Reduction in side effects of risperidone [ Time Frame: baseline, every two weeks for study duration ] [ Designated as safety issue: Yes ]
  • Abnormality in P50 inhibition [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
  • Nicotine use among all participants who smoke [ Time Frame: baseline, week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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 and perceptual disturbances and 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 will include assessments of cognitive functioning and treatment safety and effectiveness. Participants will also report the number of cigarettes they smoke per day and provide blood and urine samples to monitor medication levels and adherence.

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: 1
    Tropisetron
    Interventions:
    • Drug: Tropisetron
    • Drug: Risperidone
  • Placebo Comparator: 2
    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.
 
Recruiting
200
April 2010
March 2010   (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:

  • 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: Thomas Kosten, MD 713-794-7032 kosten@bcm.edu
Contact: Xiang Y. Zhang, MD 713-791-1414 ext 5825 xyzhang@bcm.edu
United States,   China
 
NCT00435370
U01 MH079639, DATR A5-ETPD
No
Thomas Kosten, MD, Baylor College of Medicine
National Institute of Mental Health (NIMH)
Not Provided
Principal Investigator: Thomas Kosten, MD Baylor College of Medicine
National Institute of Mental Health (NIMH)
March 2009

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