CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
sertraline 50 mg daily +2 moredrug
Likely dose
sertraline 50 mg dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00701675
NCT00701675Phase 4Completed

Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

VA Office of Research and Development·interventional·Posted Jun 19, 2008·Updated Dec 29, 2016

In Brief

A Phase 4 clinical trial evaluating sertraline 50 mg daily, sertraline 100 mg daily, and 1 other intervention for Generalized Anxiety Disorder. Completed, enrolled 42 participants across 3 sites.

Detailed Summary

Generalized anxiety disorder (GAD) is a very common disorder in the geriatric population with prevalence rates reaching 7% and even higher rates of 8% among elderly veterans. However, despite such high prevalence treating clinicians are presently forced to address treatment issues in this population without the guidance of scientific data. This proposal aims to begin to address this void. In light of emerging information regarding efficacy of the newer anti anxiety agents, specifically the selective serotonin reuptake inhibitors (SSRIs), in the treatment of young adult GAD patients it is time to prospectively evaluate the safety and efficacy of these medications in the treatment of elderly GAD patients. Therefore, this study will examine the effects and safety of the SSRI sertraline at different doses (50mg and 100mg per day) for older patients with GAD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 19, 2008
Enrollment StartOct 1, 2005
Primary CompletionJul 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.0 years ago

Interventions

sertraline 50 mg dailydrug

50 mg daily

sertraline 100 mg dailydrug

100 mg daily

Placebo 50 or 100 mgdrug

50mg or 100mg matching placebo