Phase 3 /Seroquel SR Acute Mania Monotherapy - US

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Manic Disorder; Manic State; Psychoses, Manic-Depressive; Affective Psychosis, Bipolar; Mania; Manic-Depressive Psychosis

Treatments: Drug: Quetiapine fumarate (Seroquel) SR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00422123

D144CC00004

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 Mania for 3 weeks.

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

Enrollment: 447 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• Documented diagnosis of Bipolar Disorder, with most recent episode being manic or mixed
• Inpatient hospital admission for the first 4 days of study treatment

Exclusion criteria

• >8 mood episodes within the last 12 months
• Use of prohibited medication
• 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