Official Title: Protocol 331-12-282. A Phase 3, Multicenter, Randomized, Double-blind, Placebo- and Active Comparator-Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial.
Purpose of the Study: To study the efficacy of brexpiprazole using flexible dosage as adjunctive therapy to open-label antidepressant therapy (ADT) in adults with major depressive disorder (MDD)
Description: This is an 18-week study with a 30-day follow-up, randomized, double-blind placebo- and active comparator-controlled trial of flexible-dose brexpiprazole (OPC-34712). Participants will be given either Brexpiprazole + ADT, Sperquel XR +ADT or Placebo +ADT. Participant outcomes will be assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), which measures symptoms of depression, and the Sheehan Disability Scale (SDS), which evaluates impairment in the domains of social, work and family life.
Eligibility Criteria: Adults ages 18 – 65 years who meet the DMS IV criteria for MDD and are in a current MDD episode. Exclusions: women who are breast-feeding, will be or are pregnant, individuals with dementia, schizophrenia, bipolar, eating disorder, obsessive-compulsive disorder, panic disorder or post-traumatic stress disorder, substance abuse or dependency with the past 3 months, diabetes, heart disease, inability to tolerate oral medication or have previously participated in a brexpiprazole clinical trial
Study Status: Open to enrollment
Funding/Study Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.