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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Anxiety Disorders

Treatments

Drug: Quetiapine SR

Study type

Interventional

Funder types

Industry

Identifiers

NCT00314210

D1448C00012

EUDRACT Number: 2005-005055-18

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.