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



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD), Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:6/10/2018
Start Date:December 2012
End Date:November 10, 2016

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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

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.

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.

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.
We found this trial at
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