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.

Phase 1

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-BE

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 protocol-defined inclusion criteria may apply

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 protocol-defined exclusion criteria may apply

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