Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)
Status and phase
Completed
Phase 3
Conditions
Bipolar Disorder
Treatments
Drug: quetiapine fumarate
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
1,255 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
Trial contacts and locations
95
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Data sourced from clinicaltrials.gov
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