Text Size

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
History of Changes
  Purpose

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 Intervention Phase
Affective Psychosis, Bipolar
Manic Disorder
Manic-Depressive Psychosis
Mania
Manic State
Psychoses, Manic-Depressive
 Drug: Quetiapine fumarate (Seroquel) 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 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

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

Enrollment: 447
Study Start Date: January 2007
Study Completion Date: July 2007
  Eligibility

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00422123     History of Changes
Other Study ID Numbers: D144CC00004
Study First Received: January 12, 2007
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Depressive Disorder
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