Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression
This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.
Drug: Lu AA39959
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder|
- Depressive symptoms as measured by the change from baseline in total MADRS score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Global impression (Clinical Global Impression; CGI-BP-Severity/Improvement), depression/anxiety symptoms (Hamilton Depression/Anxiety scale; HAM-D/A), mania symptoms (Young Mania Rating Scale; YMRS), adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Experimental: Lu AA39959||
Drug: Lu AA39959
30mg/day; 15mg B.I.D. for 8 weeks
|Placebo Comparator: Placebo||
B.I.D. for 8 weeks
|Active Comparator: Quetiapine||
300mg/day for 8 weeks
Other Name: Seroquel
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 spend more time in depression than in (hypo)mania over their life time. The main goals for the treatment of bipolar disorder are resolution of symptoms, return to premorbid level of social functioning and prevention of future episodes.
Although there are many treatments for bipolar disorder, few are approved, and they have limitations in their use due to safety and tolerability issues. Recommendations exist to use mood stabilisers, antipsychotics or a combination thereof with or without antidepressants and the polypharmacy employed in many cases is a reason for concern. There is a major medical need for more effective treatments in monotherapy with a reduced potential for adverse effects. This study evaluates the efficacy and safety of the new drug, Lu AA39959, in treatment of depression in patients with bipolar disorder.