Depressive Disorder, Major
Conditions
Sponsors
Allergan Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition [DSM-5] criteria for MDD - Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1 - Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode - If female of childbearing potential, have a negative serum beta-human chorionic gonadotropin [beta-hCG] pregnancy test
Exclusion criteria
Exclusion criteria: - DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1 - Lifetime history of meeting DSM-5 criteria for: 1.Schizophrenia spectrum or other psychotic disorder 2.Bipolar or related disorder 3.Major neurocognitive disorder 4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study 5.Dissociative disorder 6.Posttraumatic stress disorder 7.MDD with psychotic features - Significant suicide risk, as judged by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at the end of the double-blind treatment period Baseline to end of Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in MADRS total score at 1 day after first dose of treatment Baseline to Day 1 post-first dose | — |
Countries
Europe, Japan
Outcome results
None listed