A Multinational, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Lu AA21004 in Patients with Major Depressive Disorder

INTERVENTION: Product Name: Lu AA21004 Pharmaceutical Form: Tablet Current Sponsor code: Lu AA21004‐HBr Other descriptive name: 1‐[2‐(2,4‐Dimethyl‐phenylsulfanyl)‐phenyl]‐piperazine, hydrobromide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Lu AA21004 Pharmaceutical Form: Tablet Current Sponsor code: Lu AA21004‐HBr Other descriptive name: 1‐[2‐(2,4‐Dimethyl‐phenylsulfanyl)‐phenyl]‐piperazine, hydrobromide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Lu AA21004 Pharmaceutical Form: Tablet Current Sponsor code: Lu AA21004‐HBr Other descriptive name: 1‐[2‐(2,4‐Dimethyl‐phenylsulfanyl)‐phenyl]‐piperazine, hydrobromide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: major depressive disorder (MDD) ; MedDRA version: 12.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode ; MedDRA version: 12.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the efficacy of 3 fixed doses of Lu AA21004 (5, 10 and 20 mg QD) compared with placebo as assessed by the Montgomery‐Åsberg Depression Rating Scale (MADRS) after 8 weeks of treatment in subjects with MDD. Primary end point(s): The primary endpoint is change from baseline in the MADRS total score after 8 weeks (last observation carried forward: LOCF) of treatment. Secondary Objective: To evaluate the efficacy of 3 fixed doses of Lu AA21004 QD compared with placebo based on other parameters of efficacy after 8 weeks of treatment.; To evaluate the effect of 3 fixed doses of Lu AA21004 QD on subject functioning compared with placebo after 8 weeks of treatment.; To evaluate the safety and tolerability of Lu AA21004 compared with placebo during the course of treatment.; ; Additional Objectives:; To evaluate the efficacy of 3 fixed doses of Lu AA21004 QD compared with placebo during the 8‐week treatment period. ; To evaluate the effect of 3 fixed doses of Lu AA21004 QD on anxiety symptoms compared with placebo after 8 weeks of treatment.; To evaluate potential discontinuation symptoms after the end of the treatment period.; To assess the treatment effect (Lu AA21004 or placebo) on suicidal ideation and behavior.; To analyze plasma concentrations of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835 in subjects with MDD for population pharmacokinetic analysis.; ; INCLUSION CRITERIA: Subject eligibility is determined according to the following criteria: 1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. The subject suffers from MDD as the primary diagnosis according to DSM‐IV‐TR criteria (classification code 296.2x and 296.3x). 4. The subject is a man or woman aged between 20 and 64 years at time of informed consent, inclusive. 5. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit. 6. The subject has a MADRS total score =26 at the Screening and Baseline Visits. 7. The subject has a CGI‐S score =4 at the Screening and Baseline Visits. 8. A female subject of childbearing potential* who is sexually active with a nonsterilized* male partner agree