CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 28 enrolled
Drug / intervention
Duloxetine +2 moredrug
Likely dose
Duloxetine 60 mg orally once dailyAI-extracted
Key inclusion· 5
  • Age >18 years, outpatient status
  • Primary diagnosis of generalized social anxiety disorder per DSM-IV criteria
  • LSAS (Liebowitz Social Anxiety Scale) score >50
  • No clinically significant abnormalities on physical exam, ECG, or lab work
Key exclusion· 11
  • History of intolerance or lack of response to prior duloxetine trial at highest tolerated dose <120 mg/day
  • Acute narrow-angle glaucoma
  • Pregnant, lactating, or women of childbearing potential not using medically accepted contraception
  • Concurrent psychotropic medications; benzodiazepines/antidepressants must be discontinued ≥1 week before baseline (≥5 weeks for fluoxetine)

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

Search/NCT00114127
NCT00114127Phase 3Completed

Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

Massachusetts General Hospital·interventional·Posted Jun 14, 2005·Updated Jun 10, 2014

In Brief

A Phase 3 clinical trial evaluating Duloxetine and Placebo for Anxiety Disorder. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the safety and efficacy of duloxetine for the treatment of social anxiety disorder.

Study Details

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

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 14, 2005
Enrollment StartJun 1, 2004
Primary CompletionNov 1, 2008
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 21.1 years ago

Interventions

Duloxetinedrug

60 mg duloxetine 1x per day

Duloxetinedrug

60 mg duloxetine 1x per day + 60mg duloxetine 1x per day

Placebodrug

60mg placebo 1x per day