Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Vortioxetine (Lu AA21004)

• Registration Number: NCT00596817
• Lead Sponsor: H. Lundbeck A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-08
• Study First Posted: 2008-01-17
• Primary Completion: 2009-09
• Study Completion: 2009-10
• Results First Submitted: 2013-10-28
• Status Verified: 2014-02
• Results First Submitted QC: 2014-02-13
• Last Update Submitted: 2014-02-13
• Results First Posted: 2014-03-31
• Last Update Posted: 2014-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Vortioxetine: 5 or 10 mg	Vortioxetine (Lu AA21004)	-

Primary Outcome Measures

Name	Time	Method
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	Within first 24 weeks of the double-blind period	The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe.

Secondary Outcome Measures

Name	Time	Method
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	Within 64 weeks of the double-blind period
Change From Double-blind Baseline in MADRS Total Score After 24 Weeks of Double-blind Treatment	Double-blind Baseline and Week 24 of the double-blind period
Change From Double-blind Baseline in HAM-A Total Score After 24 Weeks of Double-blind Treatment	Double-blind Baseline and Week 24 of the double-blind period	The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms. Each symptom is rated from 0 (absent) to 4 (maximum severity). Total score from 0 to 56. The higher the score, the more severe.
Change From Double-blind Baseline in CGI-S Score After 24 Weeks of Double-blind Treatment	Double-blind Baseline and Week 24 of the double-blind period	The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
Change From Double-blind Baseline in HAM-D-17 Total Score After 24 Weeks of Double-blind Treatment	Double-blind Baseline and Week 24 of the double-blind period	The Hamilton Depression Scale - 17 items (HAM-D-17) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 52. The higher the score, the more severe.
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)	Week 24 of the double-blind period (Counted From Open-label Baseline)
Proportion of Remitters at Week 24 of the Double-blind Period (Remission Defined as a MADRS Total Score <=10)	Week 24 of the double-blind period
Change From Double-blind Baseline in SDS Total Score at Week 24 of the Double-blind Period	Week 24 of the double-blind period (Counted From Double-blind Baseline)	The Sheehan Disability Scale (SDS) comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. The three items may be summed into a single dimensional measure of global functional impairment that ranges from 0 (unimpaired) to 30 (highly impaired). The higher the score, the more severe.