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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314210
Recruitment Status : Completed
First Posted : April 13, 2006
Last Update Posted : March 25, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Drug: Quetiapine SR Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 575 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Quetiapine

Primary Outcome Measures :
  1. Time from randomisation to occurrence of an anxiety event

Secondary Outcome Measures :
  1. Occurrence of an anxiety event
  2. Change from randomisation in HAM-A/CGI-S scores
  3. In HAM-A psychic/somatic anxiety factor scores
  4. In MADRS total score and in MADRS item 10 score (suicidal thought)
  5. Change in Patient Reported Outcomes (PRO): QLESQ/PSQ/SDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314210

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Sponsors and Collaborators
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Study Director: Martin Brecher, MD AstraZeneca

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00314210    
Other Study ID Numbers: D1448C00012
EUDRACT Number: 2005-005055-18
First Posted: April 13, 2006    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Generalised Anxiety Disorder
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs