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Phase 3 /Seroquel SR Acute Mania Monotherapy - US

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ClinicalTrials.gov Identifier: NCT00422123
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Affective Psychosis, Bipolar Manic Disorder Manic-Depressive Psychosis Mania Manic State Psychoses, Manic-Depressive Drug: Quetiapine fumarate (Seroquel) SR Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 447 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline to final visit in the YMRS total score

Secondary Outcome Measures :
  1. Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS.

Eligibility Criteria

Information from the National Library of Medicine

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

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.
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): NCT00422123


  Show 51 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Datto, MD AstraZeneca
Study Director: Larisa Acevedo, Ph.D AstraZeneca
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00422123     History of Changes
Other Study ID Numbers: D144CC00004
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Bipolar Disorder
Bipolar Mania
Manic Depression
Seroquel
Seroquel SR
quetiapine fumarate

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Bipolar Disorder
Affective Disorders, Psychotic
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs