CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 enrolled
Drug / intervention
Quetiapine XR +1 moredrug
Likely dose
Quetiapine XR 50 mgfrom 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/NCT00389064
NCT00389064Phase 3Completed

A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Generalised Anxiety Disorder

AstraZeneca·interventional·Posted Oct 18, 2006·Updated Apr 4, 2012

In Brief

A Phase 3 clinical trial evaluating Quetiapine XR and Placebo for Anxiety Disorders. Completed, enrolled 450 participants across 43 sites in 5 countries.

Detailed Summary

The primary purpose of this study is to evaluate whether treatment with (SEROQUEL SR) quetiapine fumarate sustained release (SR) for 9 weeks compared to placebo will improve elderly patients with generalised anxiety disorder. PLEASE NOTE: Seroquel SR and Seroquel extended release(XR) refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEstonia, Poland, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2006
Enrollment StartSep 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 19.7 years ago

Interventions

Quetiapine XRdrug

Quetiapine XR 50 mg tablets orally administered in flexible doses of 50 to 300 mg quetiapine XR once daily, in the evening for a 9-week treatment period.

Placebodrug

Matching placebo tablets orally administered in flexible doses of 50 to 300 mg once daily, in the evening for a 9-week treatment period.