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

Completed · Phase 3 · Has a placebo group

Conditions studied: Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders

In brief

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.

Key facts

Study ID

NCT01727726

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

2182

Starts

2012-12-01

Expected to finish

2016-11-10

Last updated by the study team

2018-06-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Bellflower, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Costa Mesa, California, United States
• Study site — Glendale, California, United States
• Study site — Irvine, California, United States
• Study site — Redlands, California, United States
• Study site — San Diego, California, United States
• Study site — Upland, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville Beach, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Oakland Park, Florida, United States
• Study site — Orange City, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Belmont, Massachusetts, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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