Seroquel in Bipolar Depression Versus SSRI (EMBOLDEN II)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder; Bipolar Depression; Depression

Treatments: Drug: paroxetine; Behavioral: mood stabilizing activity; Drug: quetiapine fumarate (Seroquel)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00119652

D1447C00134

Details and patient eligibility

About

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Enrollment: 676 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female out-patients aged 18 to 65 years inclusive
• Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed

Exclusion criteria

• Current period of depression lasting less than 4 weeks or more than 12 months
• Use of prohibited medication
• Substance or alcohol dependence or abuse
• Current suicide risk or suicide attempt within 6 months
• Breast feeding or pregnancy
• Clinically relevant disease or clinical finding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind