Phase III Adjunctive Therapy in Major Depressive Disorder Trial
High Enrollment & Retention
Successful Outcome
· Site exceeded enrollment by nearly 5 times original goal
· Contributed to 8% of overall enrollment of study subjects
· 90% of randomized patients completed study
Study Description
This study will evaluate the efficacy, safety, and tolerability of XXXX 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Criteria Summary
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1. Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant.
Site Met Challenges
Additional staff was hired to support an increase in enrollment, including 2 Registered Nurses to administer IV infusions.