Lorazepam-Induced Toxicity in the Aged | RxWiki

Lorazepam-Induced Toxicity in the Aged

Overview[ - collapse ][ - ]

Purpose	This study will compare the effects of an acute dose of lorazepam to a placebo in elderly patients with generalized anxiety disorder (GAD).
Condition	Anxiety Disorders Generalized Anxiety Disorder
Intervention	Drug: Lorazepam
Phase	Phase 4
Sponsor	Nathan Kline Institute for Psychiatric Research
Responsible Party	Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier	NCT00044642
First Received	September 3, 2002
Last Updated	December 5, 2013
Last verified	December 2013

Tracking Information[ + expand ][ + ]

First Received Date	September 3, 2002
Last Updated Date	December 5, 2013
Start Date	December 2000
Estimated Primary Completion Date	July 2007
Current Primary Outcome Measures	Not Provided
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Lorazepam-Induced Toxicity in the Aged
Official Title	Long-Term Lorazepam Use and Acute Toxicity in the Aged
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).
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
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic
Condition	Anxiety Disorders Generalized Anxiety Disorder
Intervention	Drug: Lorazepam
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	90
Estimated Completion Date	July 2007
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	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
Gender	Both
Ages	60 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00044642
Other Study ID Numbers	R01 MH59142
Has Data Monitoring Committee	Not Provided
Information Provided By	Nathan Kline Institute for Psychiatric Research
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
Verification Date	December 2013

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