Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.

Phase 3

Completed

• Conditions: Anxiety Disorders

• Registration Number: NCT00314210
• Lead Sponsor: AstraZeneca

Brief Summary

The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-12
• Study First Posted: 2006-04-13
• Study Completion: 2007-08
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-24
• Last Update Posted: 2009-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 575

Inclusion Criteria

• Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.

Exclusion Criteria

• Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time from randomisation to occurrence of an anxiety event

Secondary Outcome Measures

Name	Time	Method
In HAM-A psychic/somatic anxiety factor scores
In MADRS total score and in MADRS item 10 score (suicidal thought)
Occurrence of an anxiety event
Change from randomisation in HAM-A/CGI-S scores
Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS

Trial Locations

Locations (2)

Research Site; 🇬🇧 Manchester, United Kingdom

Research SIte; 🇺🇸 Middleburg Heights, Ohio, United States