A Phase 4 interventional study of Lorazepam in Anxiety Disorders and Generalized Anxiety Disorder, sponsored by Nathan Kline Institute for Psychiatric Research. Completed at 2 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-06.
Sponsored by Nathan Kline Institute for Psychiatric Research · Phase 4, Interventional, and Diagnostic
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's planned enrollment of 90 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Nathan Kline Institute for Psychiatric Research is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
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Note: Individuals who are unable or unwilling to have an MRI may be included
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This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Nathan Kline Institute for Psychiatric Research