Lorazepam-Induced Toxicity in the Aged

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Nathan Kline Institute for Psychiatric Research
ClinicalTrials.gov Identifier:
NCT00044642
First received: September 3, 2002
Last updated: December 5, 2013
Last verified: December 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Long-Term Lorazepam Use and Acute Toxicity in the Aged

Resource links provided by NLM:


Further study details as provided by Nathan Kline Institute for Psychiatric Research:

Estimated Enrollment: 90
Study Start Date: December 2000
Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044642

Locations
United States, New York
NYU/Bellevue General Clinical Research Center (8East)
New York, New York, United States, 10016
Nathan S. Kline Institute
Orangeburg, New York, United States, 10962
Sponsors and Collaborators
Nathan Kline Institute for Psychiatric Research
Investigators
Principal Investigator: Nunzio Pomara, MD Nathan S. Kline Institute and New York University School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00044642     History of Changes
Other Study ID Numbers: R01 MH59142, R01MH059142, DATR A4-GPX
Study First Received: September 3, 2002
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Nathan Kline Institute for Psychiatric Research:
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Lorazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on July 22, 2014