Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435370
Status:
COMPLETED
Last Update Posted:
2017-03-15
First Post:
2007-02-13
Brief Title:
Effectiveness of Tropisetron Plus Risperidone for Improving Cognitive and Perceptual Disturbances in Schizophrenia
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Tropisetron With Risperidone for Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effectiveness of tropisetron plus risperidone in improving cognitive 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 final outcome assessments will include cognitive functioning and treatment safety and effectiveness
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 final outcome assessments will include cognitive functioning and treatment safety and effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01MH079639 | NIH | None | httpsreporternihgovquickSearchU01MH079639 |