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.

A randomised, double-blind, parallel-group, active-controlled, flexible dose study evaluating the effects of Lu AA21004 versus agomelatine in adult patients suffering from major depressive disorder with inadequate response to antidepressant treatment

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002362-21-SE

Enrollment

500

Registered

2011-10-03

Start date

2011-11-15

Completion date

Unknown

Last updated

2013-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Product Name: Lu AA21004 Product Code: Lu AA21004 Pharmaceutical Form: Capsule INN or Proposed INN: NA Current Sponsor code: Lu AA21004 Other descriptive name: Lu AA21004 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: • 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 • 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 Exploratory objectives are described in the protocol ;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	—

Measure

Time frame

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: • 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 • 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 Exploratory objectives are described in the protocol ;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

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

Countries

Austria, Belgium, Bulgaria, Croatia, Czech Republic, Estonia, Germany, Italy, Lithuania, Poland, Romania, Russian Federation, Spain, Sweden, United Kingdom

Contacts

Public ContactLundbeckClinicalTrials@lundbeck.com

H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com+4536301311

Outcome results