|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia | ||||||||
| Official Title † | Tropisetron With Risperidone for Schizophrenia | ||||||||
| Brief Summary | This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive and perceptual disturbances and symptoms in Chinese people with schizophrenia. |
||||||||
| 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. |
||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study | ||||||||
| Primary Outcome Measure † | Cognitive deficits as assessed by tests measuring the MATRICS cognition domains [ Time Frame: Baseline, end of 12 wk treatment ] | ||||||||
| Secondary Outcome Measure † | Negative schizophrenic symptoms [ Time Frame: Screening, baseline, every 2 weeks after for duration of study ] Reduction in side effects of risperidone [ Time Frame: baseline, every two weeks for study duration ] Abnormality in P50 inhibition [ Time Frame: baseline, week 12 ] Nicotine use among all participants who smoke [ Time Frame: baseline, week 12 ] |
||||||||
| Condition † | Smoking Cessation Schizophrenia |
||||||||
| Intervention † | Drug: Tropesetron Drug: Placebo Drug: Risperdone |
||||||||
| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 200 | ||||||||
| Start Date † | November 2006 | ||||||||
| Completion Date | February 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 64 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
|
||||||||
| Location Countries † | United States, China | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00435370 | ||||||||
| Organization ID | U01 MH79639 | ||||||||
| Secondary IDs †† | DATR A5-ETPD | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | November 2007 | ||||||||
| First Received Date † | February 13, 2007 | ||||||||
| Last Updated Date | November 27, 2007 | ||||||||