Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.

Detailed Description
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Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.

Official Title
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A Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active-referenced Study Evaluating the Efficacy and Safety of Three Fixed Dose Regimens of Lu AA34893 in the Treatment of Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Lu AA34893
* Drug: Venlafaxine extended release
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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In- and out-patients with moderate to severe Major Depressive Disorder Inclusion Criteria: Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx) Moderate to severe depression Current MDE duration of at least 3 months Exclusion Criteria: Any current psychiatric disorder other than MDD as defined in the DSM-IV TR Any substance disorder within the previous 6 months Females of childbearing potential and not using adequate contraception Use of any psychoactive medication within 2 weeks before randomisation and during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: 1<br> | Drug: Lu AA34893<br>* Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period<br>|
| Experimental: 2<br> | Drug: Lu AA34893<br>* Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period<br>|
| Experimental: 3<br> | Drug: Lu AA34893<br>* Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period<br>|
| Other: 4<br> | Drug: Venlafaxine extended release<br>* Per oral, once daily, during 8 weeks, followed by a two-week tapering period<br>|
| Placebo Comparator: 5<br> | Drug: Placebo<br>* Per oral doses, twice daily as capsules during 10 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 MADRS total score |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy, Safety, Depression, Interventional, Placebo, Short-term, Major Depressive Disorder, Major Depressive Episode