Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

Detailed Description
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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.

Official Title
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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

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Lu AA39959
* Drug: Placebo
* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AA39959<br> | Drug: Lu AA39959<br>* 30mg/day; 15mg B.I.D. for 8 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* B.I.D. for 8 weeks<br>|
| Active Comparator: Quetiapine<br> | Drug: Quetiapine<br>* 300mg/day for 8 weeks<br>* Other names: Seroquel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms as measured by the change from baseline in total MADRS score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double-blind, Randomised controlled, Multicenter, Clinical study, Mania, Depression, Bipolar I Disorder, Bipolar II Disorder, Placebo-controlled