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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH059142 | U.S. NIH Grant/Contract | View source | |
| DATR A4-GPX |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).
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 2.5 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, 2.5, and 5 hours after the drug is given. Blood samples for the determination of drug levels are also obtained.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorazepam | Drug |
Inclusion Criteria:
Note: Individuals who are unable or unwilling to have an MRI may be included
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nunzio Pomara, MD | Nathan S. Kline Institute and New York University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU/Bellevue General Clinical Research Center (8East) | New York | New York | 10016 | United States | ||
| Nathan S. Kline Institute |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Orangeburg |
| New York |
| 10962 |
| United States |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |