Status:
TERMINATED
Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Depression in Patients With Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.
Detailed Description
Bipolar disorder is a common lifelong psychiatric disorder. It is characterized by recurrent mood swings with manic or hypomanic episodes alternated with depressive episodes of longer duration. Patien...
Eligibility Criteria
Inclusion
- Current major depressive episode of bipolar I or bipolar II 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 :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00622245
Start Date
January 1 2008
End Date
November 1 2009
Last Update
September 27 2010
Active Locations (50)
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1
AU001
Brisbane, Australia, 4000
2
AU003
Dandenong, Australia, 3175
3
AU002
Malvern, Australia, 3144
4
AT002
Vienna, Austria, 1010