NCT00044642

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2000

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2002

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

First QC Date

September 3, 2002

Last Update Submit

December 5, 2013

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Keywords

Anxiety

Interventions

LorazepamDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lorazepam treatment for at least 3 months
  • Cognitively intact
  • Note: Individuals who are unable or unwilling to have an MRI may be included

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYU/Bellevue General Clinical Research Center (8East)

New York, New York, 10016, United States

Location

Nathan S. Kline Institute

Orangeburg, New York, 10962, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersGeneralized Anxiety Disorder

Interventions

Lorazepam

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nunzio Pomara, MD

    Nathan S. Kline Institute and New York University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2002

First Posted

September 5, 2002

Study Start

December 1, 2000

Study Completion

July 1, 2007

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations

US(2)