Phase III/Seroquel SR Bipolar Depression Monotherapy - US

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Depression, Bipolar; Psychoses, Manic-Depressive; Affective Psychosis, Bipolar; Manic-Depressive Psychosis

Treatments: Drug: Quetiapine fumarate (Seroquel) SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422214

D144CC00002

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• Documented diagnosis of Bipolar 1 disorder or Bipolar 11 disorder
• Outpatient status at enrollment

Exclusion criteria

• Patients with >8 mood episodes during the past 12 years
• Use of prohibited medications
• Substance or alcohol abuse or dependence
• Current suicide risk or suicide attempt within last 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind