Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097032
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2004-11-17
Brief Title:
Study Measuring Differences in Cognition Due to Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Outpatients
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the sedating causing sleepiness effects of risperidone or quetiapine alter cognitive persons ability to think perceive recognize remember judge and reason functioning in subjects with stable Bipolar I Disorder
Detailed Description:
To compare the treatment effects of risperidone and quetiapine on cognitive function using measures commonly believed to be affected by sedation and at doses typically used in clinical settings in stable bipolar I outpatientsOne-half of patients are randomized to treatment sequence risperidone-quetiapine R-Q and the other one-half to quetiapine-risperidone Q-R Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing After a 6 - 14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing
Those randomized to Q-R receive the same treatments but in reverse order Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing After a 6-14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing Those randomized to Q-R receive the same treatments but in reverse order
Those randomized to Q-R receive the same treatments but in reverse order Patients randomized to R-Q receive 2 mg of risperidone with dinner the night before testing and placebo with breakfast on the day of testing After a 6-14 day washout period they receive 100 mg quetiapine with dinner the night before their second day of testing and 100 mg with breakfast the day of testing Those randomized to Q-R receive the same treatments but in reverse order
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 |
|---|---|---|---|
| RIS-OUT-184 | None | None | None |