Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00435370

Purpose

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

Condition	Intervention	Phase
Smoking Cessation Schizophrenia	Drug: Tropisetron Drug: Placebo Drug: Risperidone	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Tropisetron With Risperidone for Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Schizophrenia Smoking

Drug Information available for: Tropisetron Risperidone

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Cognitive deficits as assessed by tests measuring the MATRICS cognition domains [ Time Frame: Baseline, end of 12 wk treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	November 2006
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Tropisetron	Drug: Tropisetron 10 mg/day Other Name: Navoban Drug: Risperidone 6mg/day Other Name: Risperdal, Ridal, Rispolept
Placebo Comparator: 2	Drug: Placebo placebo Drug: Risperidone 6mg/day Other Name: Risperdal, Ridal, Rispolept

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 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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435370

Contacts

Contact: Thomas Kosten, MD	713-794-7032	kosten@bcm.edu
Contact: Xiang Y. Zhang, MD	713-791-1414 ext 5825	xyzhang@bcm.edu

Locations

United States, Texas
Baylor College of Medicine - Michael E. DeBakey VA Medical Center	Recruiting
Houston, Texas, United States, 77030
Contact: Thomas Kosten, MD 713-794-7032 kosten@bcm.edu
Contact: Tiffany L Polk, MBA 713-794-7170 tiffanyp@bcm.edu
Principal Investigator: Thomas Kosten, MD
Sub-Investigator: Xiang Y. Zhang, MD
China
Beijing Hui-Long Guan Hospital	Recruiting
Beijing, China
Contact: Da C Chen, MD
Contact: Xiang Y. Zhang, MD 713-791-1414 ext 5825 xyzhang@bcm.edu
Principal Investigator: Da C Chen, MD
Sub-Investigator: Xiang Y. Zhang, MD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Thomas Kosten, MD

Baylor College of Medicine

More Information

No publications provided

Responsible Party:	Thomas Kosten, MD, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00435370 History of Changes
Other Study ID Numbers:	U01 MH079639, DATR A5-ETPD
Study First Received:	February 13, 2007
Last Updated:	March 12, 2009
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Schizophrenia
Smoking
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Habits
Tropisetron
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on February 12, 2012