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
Overview
- Phase
- Phase 3
- Intervention
- Vortioxetine (Lu AA21004)
- Conditions
- Major Depressive Disorder
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 495
- Primary Endpoint
- Change From Baseline in MADRS Total Score at Week 8
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Vortioxetine 10 mg or 20 mg
Intervention: Vortioxetine (Lu AA21004)
Agomelatine 25 mg or 50 mg
Intervention: Agomelatine
Outcomes
Primary Outcomes
Change From Baseline in MADRS Total Score at Week 8
Time Frame: Baseline and Week 8
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, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Secondary Outcomes
- Change From Baseline in MADRS Total Score at Week 12(Baseline and Week 12)
- Change From Baseline in HAM-A Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in HAM-A Total Score at Week 12(Baseline and Week 12)
- Change From Baseline in CGI-S Score at Week 8(Baseline and Week 8)
- Change From Baseline in CGI-S Score at Week 12(Baseline and Week 12)
- Change in Clinical Status Using CGI-I Score at Week 8(Week 8)
- Change in Clinical Status Using CGI-I Score at Week 12(Week 12)
- Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Baseline and Week 8)
- Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Baseline and Week 12)
- Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)(Week 8)
- Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)(Week 12)
- Change From Baseline in SDS Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in SDS Total Score at Week 12(Baseline and Week 12)