Clinical trial NCT01488071: A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication
Official title: A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Depression
Multimodal antidepressant
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2011-12-08
Enrollment: 495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.


Eligibility criteria: Inclusion Criteria:

* The patient is being treated with a serotonin reuptake inhibitor (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
* Montgomery Åsberg Depression Rating Scale (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

Exclusion Criteria:

* The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
* The patient is at significant risk of suicide
* The patient is currently receiving formal psychotherapy or other psychoactive medications

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Change From Baseline in MADRS Total Score at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change From Baseline in MADRS Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in HAM-A Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in HAM-A Total Score at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in CGI-S Score at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in CGI-S Score at Week 12
timeFrame: Baseline and Week 12
measure: Change in Clinical Status Using CGI-I Score at Week 8
timeFrame: Week 8
measure: Change in Clinical Status Using CGI-I Score at Week 12
timeFrame: Week 12
measure: Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
timeFrame: Baseline and Week 8
measure: Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
timeFrame: Baseline and Week 12
measure: Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)
timeFrame: Week 8
measure: Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)
timeFrame: Week 12
measure: Change From Baseline in SDS Total Score at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in SDS Total Score at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Papakostas GI, Nielsen RZ, Dragheim M, Tonnoir B. Efficacy and tolerability of vortioxetine versus agomelatine, categorized by previous treatment, in patients with major depressive disorder switched after an inadequate response. J Psychiatr Res. 2018 Jun;101:72-79. doi: 10.1016/j.jpsychires.2018.02.017. Epub 2018 Feb 22.
citation: Montgomery SA, Nielsen RZ, Poulsen LH, Haggstrom L. A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum Psychopharmacol. 2014 Sep;29(5):470-82. doi: 10.1002/hup.2424.