A Double-blind, Randomised, Placebo-controlled, Multicentre, Relapse-prevention Study With Two Doses of [Vortioxetine] Lu AA21004 in Patients With Major Depressive Disorder
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Major Depressive Disorder
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 639
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Placebo
Intervention: Placebo
Vortioxetine: 5 or 10 mg
Intervention: Vortioxetine (Lu AA21004)
Outcomes
Primary Outcomes
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
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
- 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))