Status:
TERMINATED
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
Detailed Description
Bipolar disorder is a common lifelong psychiatric disorder characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patients spen...
Eligibility Criteria
Inclusion
- Patients suffering from a major depressive episode of bipolar II or I disorder, according to DSM-IV TR
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00771134
Start Date
December 1 2008
End Date
August 1 2009
Last Update
May 28 2014
Active Locations (1)
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1
US024
Atlanta, Georgia, United States, 30308