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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314210
First Posted: April 13, 2006
Last Update Posted: March 25, 2009
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.
Information provided by:
AstraZeneca
  Purpose

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 Intervention Phase
Anxiety Disorders Drug: Quetiapine SR Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 575
Study Start Date: March 2006
Study Completion Date: August 2007
  Eligibility

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.


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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00314210


  Show 114 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Martin Brecher, MD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314210     History of Changes
Other Study ID Numbers: D1448C00012
EUDRACT Number: 2005-005055-18
First Submitted: April 11, 2006
First Posted: April 13, 2006
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Generalised Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs