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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00044642 |
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 | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders Generalized Anxiety Disorder |
Drug: Lorazepam |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study |
| Official Title: | Long-Term Lorazepam Use and Acute Toxicity in the Aged |
| Estimated Enrollment: | 90 |
| Study Start Date: | December 2000 |
| Study Completion Date: | July 2007 |
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Note: Individuals who are unable or unwilling to have an MRI may be included
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Nathan S. Kline Institute | |
| Orangeburg, New York, United States, 10962 | |
| NYU/Bellevue General Clinical Research Center (8East) | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Nunzio Pomara, MD | Nathan S. Kline Institute and New York University School of Medicine |
More Information
| Study ID Numbers: | R01 MH59142, DATR A4-GPX |
| Study First Received: | September 3, 2002 |
| Last Updated: | December 6, 2007 |
| ClinicalTrials.gov Identifier: | NCT00044642 History of Changes |
| Health Authority: | United States: Federal Government |
|
Anxiety |
|
Lorazepam Neurotransmitter Agents Tranquilizing Agents Anxiety Disorders Mental Disorders Hypnotics and Sedatives |
Psychotropic Drugs Antiemetics Central Nervous System Depressants Anti-Anxiety Agents Peripheral Nervous System Agents Anticonvulsants |
|
Neurotransmitter Agents Disease Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Pharmacologic Actions Lorazepam |
Pathologic Processes Anxiety Disorders Autonomic Agents Mental Disorders Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants |
