CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Ziprasidone +1 moredrug
Likely dose
Ziprasidone dose not specified in eligibility criteria or arms; sertraline dose not specifiedAI-extracted
Key inclusion· 5
  • Adults 18-65 years of age
  • Primary diagnosis of Social Anxiety Disorder using DSM-IV criteria
  • Clinical Global Impression of Severity (CGI-S) score ≥4 at baseline
  • Brief Social Phobia Scale (BSPS) score ≥20 at baseline
Key exclusion· 10
  • Current DSM-IV diagnosis of bipolar disorder, schizophrenia, other psychotic disorder, mental retardation, pervasive developmental disorder, or cognitive disorder due to general medical condition
  • Any current primary anxiety disorder other than SAD
  • Current primary depression
  • History of substance abuse or dependence within the last 3 months

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

Search/NCT00215150
NCT00215150Phase 2Completed

Ziprasidone for the Treatment of Refractory Social Anxiety Disorder

Duke University·interventional·Posted Sep 22, 2005·Updated Oct 31, 2014

In Brief

A Phase 2 clinical trial evaluating Ziprasidone and Sertraline for Social Anxiety Disorder. Completed, enrolled 51 participants across 2 sites.

Detailed Summary

The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

Study Details

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

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartNov 1, 2004
Primary CompletionDec 1, 2008
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

Ziprasidonedrug

Sertraline augmentation with ziprasidone

Sertralinedrug

Treatment by sertraline in open label phase, followed by ziprasidone/placebo randomized augmentation in the randomized phase