Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression (NCT00771134) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
Stopped: Study was previously suspended and is now terminated
United States105 participantsStarted 2008-12
Plain-language summary
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Depressive symptoms as measured by the change from baseline in total MADRS score