Lorazepam-Induced Toxicity in the Aged

Sponsor

Nathan Kline Institute for Psychiatric Research (Other)

Overall Status

Completed

CT.gov ID

NCT00044642

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Locations

78.9

Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorders Generalized Anxiety Disorder	Drug: Lorazepam	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Diagnostic

Official Title:

Long-Term Lorazepam Use and Acute Toxicity in the Aged

Study Start Date :

Dec 1, 2000

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU/Bellevue General Clinical Research Center (8East)	New York	New York	United States	10016
2	Nathan S. Kline Institute	Orangeburg	New York	United States	10962