Clinical trial NCT01727726: A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Keywords: OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 2182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).
Secondary outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).
measure: Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.
timeFrame: Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14)
measure: Clinical Global Impression Score
timeFrame: From randomization to Phase B week 6 (14/16 weeks after randomization).
measure: MADRS Response at Week 6
timeFrame: Phase B week 6 (14/16 weeks after randomization).
measure: Number of Participants With MADRS
timeFrame: Phase B week 6 (14/16 weeks after randomization).
measure: CGI-I Response Rate
timeFrame: Phase B week 6 (14/16 weeks after randomization).
measure: Number of Participants With Adverse Events
timeFrame: From screening (Day -28 to Day-1) upto post treatment follow-up.
measure: Sheehan Disability Scale (SDS) Individual Item Scores.
timeFrame: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Bellflower
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Glendale
country: United States
state: California
city: Irvine
country: United States
state: California
city: Redlands
country: United States
state: California
city: San Diego
country: United States
state: California
city: Upland
country: United States
state: California
city: Gainesville
country: United States
state: Florida
city: Jacksonville Beach
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Oakland Park
country: United States
state: Florida
city: Orange City
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Lake Charles
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Belmont
country: United States
state: Massachusetts
city: Roslindale
country: United States
state: Massachusetts
city: Watertown
country: United States
state: Massachusetts
city: Creve Coeur
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Edmond
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: Murray
country: United States
state: Utah
city: Herndon
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
city: Seattle
country: United States
state: Washington
city: Brown Deer
country: United States
state: Wisconsin
city: Penticton
country: Canada
state: British Columbia
city: Dijon
country: France
city: Douai
country: France
city: Elancourt
country: France
city: Jarnac
country: France
city: Montepellier
country: France
city: Orvault
country: France
city: Achim
country: Germany
city: Mittweida
country: Germany
city: Stralsund
country: Germany
city: Wuerzburg
country: Germany
city: Belchatow
country: Poland
city: Bydgoszcz
country: Poland
city: Gdynia
country: Poland
city: Kielce
country: Poland
city: Lublin
country: Poland
city: Tuszyn
country: Poland
city: Wroclaw
country: Poland
city: Arkhangelsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Tonnelniy
country: Russian Federation
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Novi Knezevac
country: Serbia
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Mary Hobart
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.