Clinical trial NCT00596817: Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
Official title: A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Relapse prevention
Antidepressants
Placebo-controlled
Double-blind
Multicentre study
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2008-01-17
Enrollment: 639
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: This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major depressive episodes in patients who responded to open-label treatment with Vortioxetine.


Eligibility criteria: Inclusion Criteria:

* Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR criteria
* At least one other MDE before the current one
* Moderate to severe depression

Exclusion Criteria:

* Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined in the DSM-IV TR
* Any substance disorder within the previous 6 months
* Female patients of childbearing potential who are not using effective contraception
* Use of any psychoactive medication 2 weeks prior to screening and during the study

Randomisation Criteria: Patients in remission (MADRS total score \<=10) at both Week 10 and Week 12

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Relapse Within First 24 Weeks of the Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
timeFrame: Within first 24 weeks of the double-blind period
Secondary outcomes:
measure: Relapse During the Entire Double-blind Period Based on a MADRS Total Score >=22 or an Unsatisfactory Treatment Effect (Lack of Efficacy) as Judged by the Investigator
timeFrame: Within 64 weeks of the double-blind period
measure: Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment
timeFrame: Double-blind Baseline and Week 24 of the double-blind period
measure: Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment
timeFrame: Double-blind Baseline and Week 24 of the double-blind period
measure: Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment
timeFrame: Double-blind Baseline and Week 24 of the double-blind period
measure: Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment
timeFrame: Double-blind Baseline and Week 24 of the double-blind period
measure: Proportion of Responders at Week 24 of the Double-blind Period (Response Defined as a >=50% Reduction in MADRS Total Score From Open-label Baseline)
timeFrame: Week 24 of the double-blind period (Counted From Open-label Baseline)
measure: Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)
timeFrame: Week 24 of the double-blind period
measure: Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period
timeFrame: Week 24 of the double-blind period (Counted From Double-blind Baseline)
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Boulenger JP, Loft H, Florea I. A randomized clinical study of Lu AA21004 in the prevention of relapse in patients with major depressive disorder. J Psychopharmacol. 2012 Nov;26(11):1408-16. doi: 10.1177/0269881112441866. Epub 2012 Apr 9.
citation: Christensen MC, Florea I, Loft H, McIntyre RS. Efficacy of vortioxetine in patients with major depressive disorder reporting childhood or recent trauma. J Affect Disord. 2020 Feb 15;263:258-266. doi: 10.1016/j.jad.2019.11.074. Epub 2019 Nov 13.
citation: McIntyre RS, Florea I, Tonnoir B, Loft H, Lam RW, Christensen MC. Efficacy of Vortioxetine on Cognitive Functioning in Working Patients With Major Depressive Disorder. J Clin Psychiatry. 2017 Jan;78(1):115-121. doi: 10.4088/JCP.16m10744.