Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044642
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2002-09-03
Brief Title:
Lorazepam-Induced Toxicity in the Aged
Sponsor:
Nathan Kline Institute for Psychiatric Research
Organization:
Nathan Kline Institute for Psychiatric Research
Study Overview
Official Title:
Long-Term Lorazepam Use and Acute Toxicity in the Aged
Status:
COMPLETED
Status Verified Date:
2013-12
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 effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder GAD
Detailed Description:
GAD is among the most common anxiety disorders in the elderly population The drug lorazepam is widely utilized in the treatment of elderly individuals with GAD However single doses of lorazepam have been associated with cognitive toxicity that is typically evident between 1 and 25 hours after the drug is administered The toxic effects include decreased memory and increased swaying which has been associated with greater risk for falls
Patients have 4 study visits A psychiatric evaluation and a memory test are given at the first visit During the second study visit patients have a physical exam an electrocardiogram ECG a neuropsychological assessment an optional magnetic resonance imaging MRI brain scan and other laboratory tests On the third and fourth visits patients are randomized to receive either their highest daily dose of lorazepam or placebo Performance effects and postural sway are determined before drug administration and at 1 25 and 5 hours after the drug is given Blood samples for the determination of drug levels are also obtained
Patients have 4 study visits A psychiatric evaluation and a memory test are given at the first visit During the second study visit patients have a physical exam an electrocardiogram ECG a neuropsychological assessment an optional magnetic resonance imaging MRI brain scan and other laboratory tests On the third and fourth visits patients are randomized to receive either their highest daily dose of lorazepam or placebo Performance effects and postural sway are determined before drug administration and at 1 25 and 5 hours after the drug is given Blood samples for the determination of drug levels are also obtained
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 |
|---|---|---|---|
| DATR A4-GPX | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH059142 |
| R01MH059142 | NIH | None | None |