Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
NCT ID: NCT01360866
Last Updated: 2018-09-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2944 participants
INTERVENTIONAL
2011-10-31
2017-05-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OPC-34712 (Brexpiprazole) and Escitalopram
OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
OPC-34712
Tablet
Escitalopram
Tablet
OPC-34712 and Fluoxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
OPC-34712
Tablet
Fluoxetine
Capsule
OPC-34712 and Paroxetine CR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
OPC-34712
Tablet
Paroxetine CR
Controlled-release tablets
OPC-34712 and Sertraline
OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
OPC-34712
Tablet
Sertraline
Tablets
OPC-34712 and Duloxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
OPC-34712
Tablet
Duloxetine
Delayed-release capsules
OPC-34712 and Venlafaxine XR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day
OPC-34712
Tablet
Venlafaxine XR
Extended-release capsules
Interventions
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OPC-34712
Tablet
Escitalopram
Tablet
Fluoxetine
Capsule
Paroxetine CR
Controlled-release tablets
Sertraline
Tablets
Duloxetine
Delayed-release capsules
Venlafaxine XR
Extended-release capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
* Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Research Site
Kharkiv, , Ukraine
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Kiev, , Ukraine
Research Site
Poltava, , Ukraine
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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331-10-238
Identifier Type: -
Identifier Source: org_study_id
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