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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00090311
First received: August 25, 2004
Last updated: January 3, 2013
Last verified: January 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090311

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00090311     History of Changes
Other Study ID Numbers: D1441C00149
Study First Received: August 25, 2004
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Bipolar I Mania

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
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 September 22, 2014