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Lorazepam-Induced Toxicity in the Aged
This study has been completed.
Study NCT00044642   Information provided by National Institute of Mental Health (NIMH)
First Received: September 3, 2002   Last Updated: December 6, 2007   History of Changes

September 3, 2002
December 6, 2007
December 2000
 
 
 
Complete list of historical versions of study NCT00044642 on ClinicalTrials.gov Archive Site
 
 
 
Lorazepam-Induced Toxicity in the Aged
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).

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.

Phase IV
Interventional
Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
  • Anxiety Disorders
  • Generalized Anxiety Disorder
Drug: Lorazepam
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
90
July 2007
 

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
Both
60 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00044642
 
R01 MH59142, DATR A4-GPX
National Institute of Mental Health (NIMH)
 
Principal Investigator: Nunzio Pomara, MD Nathan S. Kline Institute and New York University School of Medicine
National Institute of Mental Health (NIMH)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP