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Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
