Bipolar Disorder
Conditions
Keywords
Bipolar I Mania
Brief summary
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.
Interventions
DRUGquetiapine fumarate
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed