A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Milsaperidone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
Vanda Pharmaceuticals
Summary
The purpose of this study is to determine the efficacy and safety of milsaperidone compared to placebo as adjunctive therapy in patients with Major Depressive Disorder
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female patient 18 to 65 years of age, inclusive; * Meets DSM-5-TR criteria for MDD * Currently having an inadequate response to antidepressant therapy as confirmed by the Investigator using the Antidepressant Treatment Response Questionnaire (ATRQ) Exclusion Criteria: * Within the patients lifetime, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD * Within 6 months of Screening, has a confirmed DSM-5-TR psychiatric diagnosis other than MDD * Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the ma…
Interventions
- DrugMilsaperidone
Oral milsaperidone
- DrugPlacebo
Oral placebo
Locations (38)
- Vanda Investigational SitePhoenix, Arizona
- Vanda Investigational SiteLittle Rock, Arkansas
- Vanda Investigational SiteGarden Grove, California
- Vanda Investigational SiteLemon Grove, California
- Vanda Investigational SiteOrange, California
- Vanda Investigational SiteSan Jose, California