Study to Evaluate 20-mg Seltorexant in Patients with Major Depressive Disorder with Insomnia Symptoms (H-55239)

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms

The purpose of this study is to evaluate the safety, efficacy, and maintenance of effect of an investigational medication in people with depression.

Inclusion Criteria:

1. Age: 18-74 years. BMI between 18-40.
2. Not more than 2 antidepressants in current episode.
3. Medically stable.

Exclusion Criteria:

1. Current or recent history of suicidal ideation.
2. Has received ECT, VNS, or DBS in the past 5 years.
3. Actively taking drugs of abuse.