Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania (ANCHOR 149)
Status and phase
Completed
Phase 3
Conditions
Bipolar Disorder
Treatments
Drug: quetiapine fumarate
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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