Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia
Recruitment status was Recruiting
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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 3 |
| 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 |
- Cognitive deficits as assessed by tests measuring the MATRICS cognition domains [ Time Frame: Baseline, end of 12 wk treatment ] [ Designated as safety issue: No ]
- 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 |
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| 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, 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 | |
| Principal Investigator: | Thomas Kosten, MD | Baylor College of Medicine |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 May 23, 2013