Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2000-12-31
2007-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
DOUBLE
Interventions
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Lorazepam
Eligibility Criteria
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Inclusion Criteria
* Cognitively intact
Note: Individuals who are unable or unwilling to have an MRI may be included
Exclusion Criteria
* 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
60 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Nathan Kline Institute for Psychiatric Research
OTHER
Principal Investigators
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Nunzio Pomara, MD
Role: PRINCIPAL_INVESTIGATOR
Nathan S. Kline Institute and New York University School of Medicine
Locations
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NYU/Bellevue General Clinical Research Center (8East)
New York, New York, United States
Nathan S. Kline Institute
Orangeburg, New York, United States
Countries
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Other Identifiers
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