Lorazepam-Induced Toxicity in the Aged

Nathan Kline Institute for Psychiatric Research

Status and phase

Completed

Phase 4

Conditions

Generalized Anxiety Disorder

Anxiety Disorders

Treatments

Drug: Lorazepam

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00044642

DATR A4-GPX

R01MH059142 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Lorazepam treatment for at least 3 months
Cognitively intact

Note: Individuals who are unable or unwilling to have an MRI may be included

Exclusion criteria

Major psychiatric disorder other than GAD
Significant medical illness which may increase the likelihood of adverse reactions to lorazepam
Severe loss of hearing or vision
Current or past history of alcohol dependence
Substance abuse within the past 6 months
MRI evidence of infection, infarction, or other lesions suggestive of intervening neurological disease
Clinical symptoms that suggest neurological disease
Dementia or other mental syndromes or disorders