Seroquel in Bipolar Depression Versus SSRI

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Paroxetine; Quetiapine Fumarate

Criteria

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