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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00314210
First received: April 11, 2006
Last updated: March 24, 2009
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314210

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

No publications provided

ClinicalTrials.gov Identifier: NCT00314210     History of Changes
Other Study ID Numbers: D1448C00012, EUDRACT Number: 2005-005055-18
Study First Received: April 11, 2006
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Generalised Anxiety Disorder

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

ClinicalTrials.gov processed this record on May 16, 2013