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
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.
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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.
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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