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

A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314210

Acronym

PLATINUM

Enrollment

575

Registered

2006-04-13

Start date

2006-03-31

Completion date

2007-08-31

Last updated

2009-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorders

Keywords

Generalised Anxiety Disorder

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.

Interventions

DRUGQuetiapine SR

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Time from randomisation to occurrence of an anxiety event	—

Secondary

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

Countries

Australia, Canada, Finland, Germany, Hungary, Indonesia, Philippines, Russia, South Korea, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026