Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 437
- Primary Endpoint
- Change From Baseline in MADRS Total Score at Week 8
Study Overview
Brief Summary
This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
- •The patient has a MADRS total score ≥26
- •The patient has a CGI-S score ≥4
- •The reported duration of the current MDE is ≥3 months.
- •Other inclusion criteria may apply.
Exclusion Criteria
- •The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.
Arms & Interventions
Vortioxetine (Lu AA21004)
Intervention: Vortioxetine (Lu AA21004) (Drug)
Venlafaxine extended release
Intervention: Venlafaxine extended release (Drug)
Outcomes
Primary Outcomes
Change From Baseline in MADRS Total Score at Week 8
Time Frame: Baseline and Week 8
Montgomery and Asberg Depression Rating Scale (MADRS) is a ten-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at two-point intervals. The total score of the ten items ranges from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Secondary Outcomes
- Change in CGI-S Score From Baseline to Week 8(Baseline and Week 8)
- CGI-I Score at Week 8(Week 8)
- Change in HAM-A Total Score From Baseline to Week 8(Baseline and Week 8)
- MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)(Week 8)
- Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)(Week 8)
- Number of Adverse Events(Baseline to Week 12)