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| Sponsored by: |
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: Tropesetron Drug: Placebo Drug: Risperdone |
Phase III |
| MedlinePlus related topics: | Schizophrenia Smoking Smoking Cessation |
| ChemIDplus related topics: | Risperidone Tropisetron |
| 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 |
| Arms | Assigned Interventions |
|
1: Experimental
Tropesetron
|
Drug: Tropesetron
10 mg/day
Drug: Risperdone
6mg/day
|
| 2: Placebo Comparator |
Drug: Placebo
placebo
Drug: Risperdone
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Thomas Kosten, MD | 713-794-7032 | kosten@bcm.edu |
| Contact: Xiang Y. Zhang, MD | 713-791-1414 ext 824 | 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: Tracie Gardner, PhD 713-794-7170 tgardner@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 5824 xyzhang@bcm.edu | |||||
| Principal Investigator: D. F. Zhou, MD | |||||
| Sub-Investigator: Xiang Y. Zhang, MD | |||||
| Principal Investigator: | Thomas Kosten, MD | Baylor College of Medicine |
More Information
| Study ID Numbers: | U01 MH79639, DATR A5-ETPD |
| First Received: | February 13, 2007 |
| Last Updated: | November 27, 2007 |
| ClinicalTrials.gov Identifier: | NCT00435370 |
| Health Authority: | United States: Federal Government |
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