Phase 3 /Seroquel SR Acute Mania Monotherapy - US

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00422123
First received: January 12, 2007
Last updated: March 24, 2009
Last verified: March 2009

January 12, 2007
March 24, 2009
January 2007
Not Provided
Change from baseline to final visit in the YMRS total score
Same as current
Complete list of historical versions of study NCT00422123 on ClinicalTrials.gov Archive Site
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Same as current
Not Provided
Not Provided
 
Phase 3 /Seroquel SR Acute Mania Monotherapy - US
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.

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
  • Affective Psychosis, Bipolar
  • Manic Disorder
  • Manic-Depressive Psychosis
  • Mania
  • Manic State
  • Psychoses, Manic-Depressive
Drug: Quetiapine fumarate (Seroquel) SR
Not Provided
Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
447
July 2007
Not Provided

Inclusion Criteria:

  • Provision of written informed consent
  • Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
  • Inpatient hospital admission for the first 4 days of study treatment

Exclusion Criteria:

  • >8 mood episodes within the last 12 months
  • Use of prohibited medication
  • Substance or alcohol abuse or dependence
  • Current suicide risk or suicide attempt within last 6 months.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00422123
D144CC00004
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Catherine Datto, MD AstraZeneca
Study Director: Larisa Acevedo, Ph.D AstraZeneca
AstraZeneca
March 2009

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