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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00435370 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Tropisetron With Risperidone for Schizophrenia |
Estimated Enrollment: | 200 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Tropisetron
|
Drug: Tropisetron
10 mg/day
Drug: Risperidone
6mg/day
|
2: Placebo Comparator |
Drug: Placebo
placebo
Drug: Risperidone
6mg/day
|
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.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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: D. F. Zhou, MD | |
Contact: Xiang Y. Zhang, MD 713-791-1414 ext 5825 xyzhang@bcm.edu | |
Principal Investigator: D. F. Zhou, MD | |
Sub-Investigator: Xiang Y. Zhang, MD |
Principal Investigator: | Thomas Kosten, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Thomas Kosten, MD ) |
Study ID Numbers: | U01 MH79639, DATR A5-ETPD |
Study First Received: | February 13, 2007 |
Last Updated: | October 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00435370 |
Health Authority: | United States: Federal Government |
Schizophrenia Smoking Dopamine Mental Disorders Risperidone |
Tropisetron Psychotic Disorders Serotonin Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Gastrointestinal Agents Central Nervous System Depressants Antiemetics Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |