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Lorazepam-Induced Toxicity in the Aged

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ClinicalTrials.gov Identifier: NCT00044642
Recruitment Status : Completed
First Posted : September 5, 2002
Last Update Posted : December 6, 2013
National Institute of Mental Health (NIMH)
Information provided by:
Nathan Kline Institute for Psychiatric Research

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 Type : Interventional  (Clinical Trial)
Estimated 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 : December 2000
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Lorazepam
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044642

United States, New York
NYU/Bellevue General Clinical Research Center (8East)
New York, New York, United States, 10016
Nathan S. Kline Institute
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
National Institute of Mental Health (NIMH)
Principal Investigator: Nunzio Pomara, MD Nathan S. Kline Institute and New York University School of Medicine

Additional Information:
ClinicalTrials.gov Identifier: NCT00044642     History of Changes
Other Study ID Numbers: R01MH059142 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2002    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by Nathan Kline Institute for Psychiatric Research:

Additional relevant MeSH terms:
Anxiety Disorders
Pathologic Processes
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action