A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

• Status: Completed
• Trial end date: 2016-11-10
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Brexpiprazole; Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent.

• Subjects with both a diagnosis of MDD, and in a current major depressive episode, as defined by DSM-IV-TR criteria

• Subjects willing to discontinue all prohibited psychotropic medications to meet protocol-required washouts prior to and during the trial period.

Exclusion Criteria:

• Females who are breast-feeding and/or who have a positive pregnancy test result during screening prior to receiving trial medication

• Subject has a current Axis I (DSM-IV-TR) diagnosis of: dementia, Schizophrenia, Bipolar, Eating disorder , Obsessive-compulsive disorder, Panic disorder, Posttraumatic stress disorder

• Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current major depressive episode.

• Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days

• Subjects currently treated with insulin for diabetes.

• Subjects with uncontrolled hypertension

• Subjects with known ischemic heart disease or history of myocardial infarction, congestive heart failure, angioplasty, stenting, or coronary artery bypass Surgery

• Subjects with a positive drug screen for cocaine, marijuana, or other illicit drugs

• Inability to swallow tablets or tolerate oral medication

• Abnormal laboratory test results, vital signs and ECG results

• Subjects who previously participated in any prior brexpiprazole clinical trial.