A study of the new pharmaceutical LuAA21004 in comparison to agomelatine in adults suffering from major depression who did not respond well to previous medication.

Conditions: -Major Depressive Disorder (MDD)
MedDRA version: 14.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2011-002362-21-LT

Lead Sponsor: H. Lundbeck A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

•The patient is a man or woman, between 18 and 75 years old (inclusive)
•The patient is being treated with an SRI antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
•The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
•MADRS total score =22 at the Screening Visit and Baseline
•The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

Other inclusion criteria will apply as per protocol section 4.3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 395
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

•The patient has any current Axis I disorders (DSM-IV criteria) other than MDD, GAD and SAD
•The patient is at significant risk of suicide
•The patient is currently receiving formal psychotherapy or otherpsychoactive medications

Other exclusion criteria will apply as per protocol section 4.3

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of flexible doses of Lu AA21004 (10 to 20 mg/day) versus flexible doses of agomelatine (25 to 50 mg/day) after 8 weeks of treatment, on depressive symptoms in patients with Major Depressive Disorder (MDD) who have responded inadequately to Serotonin Reuptake Inhibitor (SRI) antidepressant monotherapy.;Secondary Objective: To compare:<br>•The efficacy of flexible doses of Lu AA21004 (10 to 20 mg/day) versus flexible doses of agomelatine (25 to 50 mg/day) over the 12 weeks of treatment on Depressive symptoms<br>•The safety and tolerability of flexible doses of Lu AA21004 (10 to 20 mg/day) versus flexible doses of agomelatine (25 to 50 mg/day) over the 12 weeks of treatment<br><br>Exploratory objectives are described in the protocol<br>;Primary end point(s): The change in MADRS total score from baseline to Week 8;Timepoint(s) of evaluation of this end point: Baseline and Week 8

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Change from baseline to Weeks 1, 2, 3, 4 and 12 in the MADRS total score<br>;Timepoint(s) of evaluation of this end point: •Baseline and Weeks 1, 2, 3, 4 and 12