Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073658
Status:
COMPLETED
Last Update Posted:
2014-03-10
First Post:
2003-12-02
Brief Title:
Treating Behavioral Disturbances in Individuals With Dementia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Continuation Pharmacotherapy for Agitation of Dementia
Status:
COMPLETED
Status Verified Date:
2014-03
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 compare the safety and effectiveness two medications citalopram Celexa and risperidone Risperdal
Detailed Description:
Dementia-related behavioral disturbances have been associated with excess disability increased caregiver burden and premature institutionalization Pharmacotherapy is often necessary to treat these disturbances This study will use citalopram and risperidone to treat people with dementia-related behavior problems
Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks Limited doses of the sedative lorazepam may be administered as needed throughout the study During the first 2 weeks of the study participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized Following hospital discharge participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter Experimental laboratory measures will be collected at study start Week 1 Week 2 and every 2 weeks thereafter until Week 12 Upon study completion patients may continue to receive citalopram or risperidone under the supervision of their current physicians Three months after study completion participants may be contacted for a follow-up report of their psychiatric and medical status
Participants in this study will begin a psychotropic medication washout period for up to 3 days at study start Participants will then be randomly assigned to receive either citalopram or risperidone for up to 12 weeks Limited doses of the sedative lorazepam may be administered as needed throughout the study During the first 2 weeks of the study participants will be admitted to a hospital to have their dementia-related behavioral disturbances stabilized Following hospital discharge participants will move to a long-term care facility or a residential home and will continue medication treatment for up to 10 weeks Side effects and improvements in behavioral status will be assessed every week until Week 6 and every 2 weeks thereafter Experimental laboratory measures will be collected at study start Week 1 Week 2 and every 2 weeks thereafter until Week 12 Upon study completion patients may continue to receive citalopram or risperidone under the supervision of their current physicians Three months after study completion participants may be contacted for a follow-up report of their psychiatric and medical status
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 |
|---|---|---|---|
| DSIR GT-GP | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH059666-02 |
| R01MH059666-02 | NIH | None | None |