Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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

Key facts

Study ID

NCT00771134

Run by

H. Lundbeck A/S

People needed

105

Starts

2008-12-01

Expected to finish

2009-08-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• US024 — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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