Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Bipolar Depression

Treatments: Drug: Quetiapine Immediate Release; Drug: Quetiapine Extended Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00926393

D1443C00040

Details and patient eligibility

About

The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Enrollment: 139 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed
• Outpatient status as enrollment

Exclusion criteria

• Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.

Trial design

139 participants in 2 patient groups

Quetiapine Immediate Release (IR)

Active Comparator group

Description:

Quetiapine 25, 100, 200 and 300 mg

Treatment:

Drug: Quetiapine Immediate Release

Quetiapine Extended Release (XR)

Active Comparator group

Description:

Quetiapine 50, 200, 300

Treatment:

Drug: Quetiapine Extended Release