Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder
Recruiting
Phase 3
Interventional Study
Major Depressive Disorder (MDD)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 500 (estimated)
- Sponsor
- Vanda Pharmaceuticals · Industry
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About This Trial
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
Trial Locations
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Eligibility Criteria
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:…
Contacts