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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

April 11, 2006
March 24, 2009
March 2006
Not Provided
Time from randomisation to occurrence of an anxiety event
Same as current
Complete list of historical versions of study NCT00314210 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Anxiety Disorders
Drug: Quetiapine SR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
575
August 2007
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Finland,   Germany,   Hungary,   Indonesia,   Korea, Republic of,   Philippines,   Russian Federation,   United Kingdom
 
NCT00314210
D1448C00012, EUDRACT Number: 2005-005055-18
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Martin Brecher, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP