A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
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
1 other identifier
interventional
2,182
7 countries
76
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2012
Typical duration for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2016
CompletedResults Posted
Study results publicly available
June 8, 2018
CompletedJune 8, 2018
May 1, 2018
3.9 years
October 31, 2012
January 3, 2018
May 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery Asberg Depression Rating Scale (MADRS)
To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression.
Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).
Secondary Outcomes (8)
Sheehan Disability Scale (SDS)
Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).
Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.
Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14)
Clinical Global Impression Score
From randomization to Phase B week 6 (14/16 weeks after randomization).
MADRS Response at Week 6
Phase B week 6 (14/16 weeks after randomization).
Number of Participants With MADRS
Phase B week 6 (14/16 weeks after randomization).
- +3 more secondary outcomes
Study Arms (3)
Placebo + ADT
PLACEBO COMPARATORMatching Placebo and assigned ADT
Brexpiprazole + ADT
EXPERIMENTALBrexpiprazole, flexible dose and assigned ADT
Seroquel XR + ADT
ACTIVE COMPARATORSeroquel XR, flexible dose and assigned ADT
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
Unknown Facility
Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Bellflower, California, United States
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Beverly Hills, California, United States
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Costa Mesa, California, 92626, United States
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Glendale, California, United States
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Irvine, California, United States
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Redlands, California, United States
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San Diego, California, United States
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Upland, California, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Leesburg, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, 33015, United States
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Miami, Florida, 33145, United States
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Oakland Park, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Decatur, Georgia, United States
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Lake Charles, Louisiana, United States
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Baltimore, Maryland, United States
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Belmont, Massachusetts, United States
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Roslindale, Massachusetts, United States
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Watertown, Massachusetts, 02472, United States
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Creve Coeur, Missouri, United States
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Lebanon, New Hampshire, United States
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New York, New York, 10003, United States
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New York, New York, 10168, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Edmond, Oklahoma, 73013, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Dallas, Texas, United States
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Murray, Utah, United States
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Herndon, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Brown Deer, Wisconsin, United States
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Penticton, British Columbia, Canada
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Dijon, France
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Douai, France
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Élancourt, France
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Jarnac, France
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Montepellier, France
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Orvault, France
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Achim, Germany
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Mittweida, Germany
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Stralsund, Germany
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Würzburg, Germany
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Bełchatów, Poland
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Bydgoszcz, Poland
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Gdynia, Poland
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Kielce, Poland
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Lublin, Poland
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Tuszyn, Poland
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Wroclaw, Poland
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Arkhangelsk, 163530, Russia
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Moscow, 107076, Russia
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Moscow, 127083, Russia
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Saint Petersburg, 190020, Russia
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Saint Petersburg, 191040, Russia
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Saint Petersburg, 192019, Russia
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Saint Petersburg, 199034, Russia
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Smolensk, Russia
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Tonnelniy, Russia
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Belgrade, 11000, Serbia
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Belgrade, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Novi Kneževac, Serbia
Related Publications (2)
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.
PMID: 31577867DERIVEDHobart 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.
PMID: 30508090DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Officials
- STUDY DIRECTOR
Mary Hobart
Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 16, 2012
Study Start
December 1, 2012
Primary Completion
October 17, 2016
Study Completion
November 10, 2016
Last Updated
June 8, 2018
Results First Posted
June 8, 2018
Record last verified: 2018-05