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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: quetiapine fumarate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00090311
D1441C00149

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

10 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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