Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Orion
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial
1 other identifier
interventional
2,944
11 countries
142
Brief Summary
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (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 Oct 2011
Longer than P75 for phase_3
142 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
May 24, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2017
CompletedResults Posted
Study results publicly available
September 17, 2018
CompletedSeptember 17, 2018
September 1, 2018
5.6 years
May 24, 2011
May 25, 2018
September 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse Events (AEs) - All Participants
To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.
From screening to week 52/early termination
Secondary Outcomes (4)
Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
From screening to week 52/early termination
Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
From screening to week 52/early termination
Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
From screening to week 52/early termination
Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
From screening to week 52/early termination
Study Arms (6)
OPC-34712 (Brexpiprazole) and Escitalopram
EXPERIMENTALOPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
OPC-34712 and Fluoxetine
EXPERIMENTALOPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
OPC-34712 and Paroxetine CR
EXPERIMENTALOPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
OPC-34712 and Sertraline
EXPERIMENTALOPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
OPC-34712 and Duloxetine
EXPERIMENTALOPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
OPC-34712 and Venlafaxine XR
EXPERIMENTALOPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day
Interventions
Tablet
Eligibility Criteria
You may qualify if:
- Male and Female outpatients 18-65 years of age
- Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:
- Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
- Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial
- Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:
- Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.
You may not qualify if:
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
- Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (142)
Research Site
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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Beverly Hills, California, United States
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Costa Mesa, California, United States
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Glendale, California, United States
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Irvine, California, United States
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Oceanside, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Sherman Oaks, California, United States
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Temecula, California, United States
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Upland, California, United States
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Norwalk, Connecticut, United States
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Coral Gables, Florida, United States
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Coral Springs, Florida, United States
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Fort Myers, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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Oakland Park, Florida, United States
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Orlando, Florida, United States
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The Villages, Florida, United States
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Winter Park, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Smyrna, Georgia, United States
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Oak Brook, Illinois, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Lake Charles, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Belmont, Massachusetts, United States
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Boston, Massachusetts, United States
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Methuen, Massachusetts, United States
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Watertown, Massachusetts, United States
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Weymouth, Massachusetts, United States
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Rochester Hills, Michigan, United States
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Creve Coeur, Missouri, United States
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Las Vegas, Nevada, United States
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Cherry Hill, New Jersey, United States
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Tom River, New Jersey, United States
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Brooklyn, New York, United States
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Jamaica, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Allentown, Pennsylvania, United States
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Bala-Cynwyd, Pennsylvania, United States
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Bridgeville, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Lincoln, Rhode Island, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Murray, Utah, United States
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Woodstock, Vermont, United States
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Charlottesville, Virginia, 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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Spokane, Washington, United States
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Brown Deer, Wisconsin, United States
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Middleton, Wisconsin, United States
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Gatineau, Canada
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Penticton, Canada
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Pointe-Claire, Canada
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Sherbrooke, Canada
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Toronto, Canada
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Arcachon, France
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Douai, France
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Élancourt, France
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Jarnac, France
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Orvault, France
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Palaiseau, France
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Toulouse, France
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Achim, Germany
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Bochum, Germany
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Mittweida, Germany
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Stralsund, Germany
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Würzburg, Germany
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Budapest, Hungary
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Bełchatów, Poland
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Bydgoszcz, Poland
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Katowice, Poland
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Kielce, Poland
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Lublin, Poland
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Poznan, Poland
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Pruszcz Gdański, Poland
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Tuszyn, Poland
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Wroclaw, Poland
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Bucharest, Romania
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Iași, Romania
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Târgu Mureş, Romania
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Arkhangelsk Region, Russia
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Moscow, Russia
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Roshchino, Russia
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Rostov-on-Don, Russia
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Saint Petersberg, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Tonnel’nyy, Russia
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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
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Bratislava, Slovakia
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Košice, Slovakia
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Michalovce, Slovakia
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Chernihiv, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Poltava, Ukraine
Related Publications (2)
Newcomer JW, Meehan SR, Chen D, Brubaker M, Weiss C. Changes in Metabolic Parameters and Body Weight in Patients With Prediabetes Treated With Adjunctive Brexpiprazole for Major Depressive Disorder: Pooled Analysis of Short- and Long-Term Clinical Studies. J Clin Psychiatry. 2023 Aug 28;84(5):23m14786. doi: 10.4088/JCP.23m14786.
PMID: 37656180DERIVEDNewcomer 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: 31577867DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2011
First Posted
May 26, 2011
Study Start
October 1, 2011
Primary Completion
April 18, 2017
Study Completion
May 18, 2017
Last Updated
September 17, 2018
Results First Posted
September 17, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share