Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Quetiapine Fumarate

Criteria

Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR

Inclusion Criteria:

• Current major depressive episode of bipolar II or I disorder, according to DSM-IV TR

• Moderate to severe depression

• History of at least one documented mania or hypomania episode

• Absence of current mania or hypomania

Exclusion Criteria:

• Any current psychiatric disorder other than bipolar disorder defined in the DSM-IV TR

• Any substance disorder with the previous 6 months

• Use of any psychoactive medication (including mood stabilizers) within 2 weeks before randomisation and during the study

• ECT within 6 months before the study

• Female of childbearing potential and not using adequate contraception

• Other protocol-defined inclusion and exclusion criteria may apply