Dose-finding Study With Lu AA24530 in Major Depressive Disorder

Study Overview
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Brief Summary
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The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

Detailed Description
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According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

Official Title
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Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Lu AA24530
* Drug: Duloxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Depressive Episode that has lasted at least 3 months Moderate to severe depression Exclusion Criteria: Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI) Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration Electroconvulsive therapy within 6 months prior to Baseline Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance The patient is pregnant or breast-feeding

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 AA24530: 5 mg<br> | Drug: Lu AA24530<br>* per oral, once daily for 6 weeks<br>|
| Experimental: Lu AA24530: 10 mg<br> | Drug: Lu AA24530<br>* per oral, once daily for 6 weeks<br>|
| Experimental: Lu AA24530: 20 mg<br> | Drug: Lu AA24530<br>* per oral, once daily for 6 weeks<br>|
| Active Comparator: Duloxetine: 60 mg<br> | Drug: Duloxetine<br>* per oral, once daily for 6 weeks<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* per oral, once daily for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate, remission rate, and safety |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy, Depressive disorder, Antidepressive agents, Depressive symptoms, Affective disorders, Randomized controlled trial, Placebo-controlled, Double-blind, Active reference, Multicenter study