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Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania (ANCHOR 149)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090311
First Posted: August 30, 2004
Last Update Posted: January 4, 2013
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.
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I mania.

Condition Intervention Phase
Bipolar Disorder Drug: quetiapine fumarate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbreviated)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Compare efficacy of Quetiapine with placebo in the treatment of bipolar I mania as assessed by the YMRS total score, change from baseline to Day 21

Secondary Outcome Measures:
  • Compare the effect of Quetiapine with placebo in change from baseline to Day 21 percentage of patients with response, defined as a ≤ 12, evaluate safety and tolerability

Enrollment: 220
Study Start Date: July 2004
Study Completion Date: July 2006
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures
  • Patient has a documented clinical diagnosis of Bipolar I mania
  • Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit

Exclusion Criteria:

  • Patients (female) must not be pregnant or lactating
  • Patients with a known intolerance or lack of response to previous treatment with quetiapine
  • Patients who have previously participated in this study
  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): NCT00090311


  Show 32 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Seroquel Medical Science Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00090311     History of Changes
Other Study ID Numbers: D1441C00149
First Submitted: August 25, 2004
First Posted: August 30, 2004
Last Update Posted: January 4, 2013
Last Verified: January 2013

Keywords provided by AstraZeneca:
Bipolar I Mania

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