Bipolar Disorder
Conditions
Keywords
Bipolar I disorder.
Brief summary
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Interventions
DRUGquetiapine fumarate
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * 18 years or older * A diagnosis of Bipolar I Disorder * Have a current manic, depressed or mixed episode * Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine * Female patients of childbearing potential must be using a reliable method of contraception
Exclusion criteria
* Pregnancy * Substance or alcohol dependence at enrollment * Unstable thyroid function * Unstable Diabetes * Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension * Use of an experimental drug within 30 days of enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time from randomization to recurrence of a mood event | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from randomization to recurrence of a manic event | — |
| Time from randomization to recurrence of a depressed event | — |
Countries
Argentina, Bulgaria, Colombia, India, Lithuania, Malaysia, Mexico, Peru, Philippines, Romania, Russia, Taiwan, Thailand, Ukraine, United States
Outcome results
None listed