Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Purpose
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
Condition
- Major Depressive Disorder (MDD)
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts 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 that is a primary diagnosis - Within 12 months of Screening, has had any other psychiatric condition (other than MDD) that has been the main focus of treatment
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Milsaperidone |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Vanda Pharmaceuticals
