A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
NCT ID: NCT01727726
Last Updated: 2018-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2182 participants
INTERVENTIONAL
2012-12-31
2016-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo + ADT
Matching Placebo and assigned ADT
Placebo
tablet/capsule
Brexpiprazole + ADT
Brexpiprazole, flexible dose and assigned ADT
Brexpiprazole
tablet/capsule
Seroquel XR + ADT
Seroquel XR, flexible dose and assigned ADT
Seroquel XR
tablet/capsule
Interventions
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Brexpiprazole
tablet/capsule
Seroquel XR
tablet/capsule
Placebo
tablet/capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mary Hobart
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Bellflower, California, United States
Beverly Hills, California, United States
Costa Mesa, California, United States
Glendale, California, United States
Irvine, California, United States
Redlands, California, United States
San Diego, California, United States
Upland, California, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jacksonville Beach, Florida, United States
Leesburg, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Oakland Park, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
Decatur, Georgia, United States
Lake Charles, Louisiana, United States
Baltimore, Maryland, United States
Belmont, Massachusetts, United States
Roslindale, Massachusetts, United States
Watertown, Massachusetts, United States
Creve Coeur, Missouri, United States
Lebanon, New Hampshire, United States
New York, New York, United States
New York, New York, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Edmond, Oklahoma, United States
Portland, Oregon, United States
Salem, Oregon, United States
Dallas, Texas, United States
Murray, Utah, United States
Herndon, Virginia, United States
Richmond, Virginia, United States
Bellevue, Washington, United States
Kirkland, Washington, United States
Seattle, Washington, United States
Brown Deer, Wisconsin, United States
Penticton, British Columbia, Canada
Dijon, , France
Douai, , France
Élancourt, , France
Jarnac, , France
Montepellier, , France
Orvault, , France
Achim, , Germany
Mittweida, , Germany
Stralsund, , Germany
Würzburg, , Germany
Bełchatów, , Poland
Bydgoszcz, , Poland
Gdynia, , Poland
Kielce, , Poland
Lublin, , Poland
Tuszyn, , Poland
Wroclaw, , Poland
Arkhangelsk, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Smolensk, , Russia
Tonnelniy, , Russia
Belgrade, , Serbia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Novi Kneževac, , Serbia
Countries
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References
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Newcomer JW, Eriksson H, Zhang P, Meehan SR, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Major Depressive Disorder Treated With Adjunctive Brexpiprazole: Pooled Analysis of Phase 3 Clinical Studies. J Clin Psychiatry. 2019 Oct 1;80(6):18m12680. doi: 10.4088/JCP.18m12680.
Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.
Other Identifiers
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331-12-282
Identifier Type: -
Identifier Source: org_study_id
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