Lorazepam-Induced Toxicity in the Aged

December 5, 2013 updated by: Nathan Kline Institute for Psychiatric Research

Long-Term Lorazepam Use and Acute Toxicity in the Aged

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU/Bellevue General Clinical Research Center (8East)
      • Orangeburg, New York, United States, 10962
        • Nathan S. Kline Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nathan Kline Institute for Psychiatric Research

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Nunzio Pomara, MD, Nathan S. Kline Institute and New York University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2000

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 3, 2002

First Submitted That Met QC Criteria

September 4, 2002

First Posted (Estimate)

September 5, 2002

Study Record Updates

Last Update Posted (Estimate)

December 6, 2013

Last Update Submitted That Met QC Criteria

December 5, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH059142 (U.S. NIH Grant/Contract)
  • DATR A4-GPX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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