Phase 3 /Seroquel SR Acute Mania Monotherapy - US

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: NCT00422123
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : March 25, 2009
Information provided by:

January 12, 2007
January 15, 2007
March 25, 2009
January 2007
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Change from baseline to final visit in the YMRS total score
Same as current
Complete list of historical versions of study NCT00422123 on Archive Site
Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.
Same as current
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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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Affective Psychosis, Bipolar
  • Manic Disorder
  • Manic-Depressive Psychosis
  • Mania
  • Manic State
  • Psychoses, Manic-Depressive
Drug: Quetiapine fumarate (Seroquel) SR
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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 Identifier (NCT Number) in Medline.
Same as current
July 2007
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Study Director: Catherine Datto, MD AstraZeneca
Study Director: Larisa Acevedo, Ph.D AstraZeneca
March 2009

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