Efficacy and Safety of Lu AA34893 in Patients With Bipolar Depression

Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder

This study will evaluate the efficacy and safety of different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

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. Patients spend more time in depression than in (hypo)mania over their life time. The medical need for the patient is to remain symptom-free for as long a period as possible. A reduction both in severity of depression and mania, and in frequency of cycling, is the aim.

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 AA34893, in treatment of depression in patients with bipolar disorder.

Inclusion Criteria:

• 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 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