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Home > "L" Clinical Trials Conditions > Lorazepam- Induced Toxicity in the Aged  Lorazepam- Induced Toxicity in the Aged
Lorazepam- Induced Toxicity in the Aged
For Condition: Anxiety Disorders
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to compare the effects of an acute dose of lorazepam to an acute dose of placebo in elderly patients with Generalized Anxiety Disorder (GAD).
Details: 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:
Study Type: Observational, Natural History, Cross-Sectional, Defined Population, Prospective Study
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Generalized Anxiety Disorder (GAD) - Anxiety or worry that is not confined to features of an Axis I disorder (i.e., panic disorder, social phobia, etc.) - Anxiety, worry, or physical symptoms that cause clinically significant distress or impairment in important areas of functioning - Symptoms that are not due to the direct physiological effects of a substance or a general medical condition and do not occur exclusively during a Mood Disorder or a Pervasive Developmental Disorder - Lorazepam treatment for at least 3 months - Mini-Mental State Examination (MMSE) score greater than 28 - Wechsler Adult Intelligence Scale (WAIS)-III Vocabulary score greater than 7 - Wechsler Memory Scale (WMS)-III General Memory Index score greater than 85 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
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
NunzioPomara, Principal Investigator, Nathan S. Kline Institute and New York University School of Medicine
NYU/Bellevue General Clinical Research Center (8East) *Recruiting*
New York City, New York, 10016
United States
Recruiting Ellie DeCandia 212-263-6411
Nathan S. Kline Institute *Recruiting*
Orangeburg, New York, 10962
United States
Recruiting Nunzio Pomara 845-398-5579
Additional Information:
Study ID Numbers: 59142-01A2;
Study Start Date: December 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044642
Other Anxiety Disorders Studies:
1. Child and Adolescent Anxiety Disorders (CAMS)
2. Family and Peer Involvement in the Treatment of Anxiety Disorders in Children
3. Preventing Anxiety Disorders in Youth
4. Pharmacologic Treatment of PTSD in Sexually Abused Children
5. Brain Changes in Fear
Related Studies:
Other Anxiety Disorders Clinical Trials
Other New York Clinical Trials
Other Orangeburg Clinical Trials
Lorazepam- Induced Toxicity in the Aged
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