Depression in Patients With Bipolar Disorder Clinical Trial
Official title:
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment