Efficacy and Safety of Lu AA34893 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 different doses of Lu AA34893 in the treatment of depression in patients with bipolar disorder.

Detailed Description
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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.

Official Title
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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

Conditions
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Depression in Patients With Bipolar Disorder

Intervention / Treatment
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* Drug: Lu AA34893
* Drug: Quetiapine fumarate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

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 AA34893: 4 mg<br> | Drug: Lu AA34893<br>* per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period<br>|
| Experimental: Lu AA34893: 12 mg<br> | Drug: Lu AA34893<br>* per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period<br>|
| Experimental: Lu AA34893: 18 mg<br> | Drug: Lu AA34893<br>* per oral doses, divided in twice daily administrations as capsules, during 12 weeks, followed by a one-week tapering period<br>|
| Other: Quetiapine fumarate<br>Active reference 300 mg | Drug: Quetiapine fumarate<br>* per oral, once daily, during 12 weeks, followed by a one-week tapering period<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* per oral doses, twice daily as capsules during 13 weeks<br>|

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 |
| --- | --- | --- |
| HAM-D, CGI-BP, responders and remitters, BDI-II, HAM-A, safety parameters YMRS, AIMS, BARS, SAS, adverse events, clinical laboratory, ECG, physical examinations |  | 12 weeks | 

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