NCT00044642

Lorazepam-Induced Toxicity in the Aged

Long-Term Lorazepam Use and Acute Toxicity in the Aged

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Nathan Kline Institute for Psychiatric Research · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Anxiety Disorders
• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Lorazepam

Timeline

• Start date: 2000-12-01
• Completion: 2007-07-01
• First posted: 2002-09-05
• Last updated: 2013-12-06

Locations

2 sites across 1 country: United States