Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
NCT ID: NCT01360632
Last Updated: 2016-01-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1539 participants
INTERVENTIONAL
2011-06-30
2013-09-30
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
TRIPLE
Study Groups
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Phase B
Drug: OPC-34712 + ADT
Drug: Placebo + ADT
OPC-34712 + ADT
Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
Phase A
Drug: Placebo + ADT
Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
Interventions
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OPC-34712 + ADT
Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
Eligibility Criteria
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Inclusion Criteria
* The current depressive episode must be equal to or greater than 8 weeks in duration
* Subjects must report a history for the current depressive episode of an inadequate response to no more than three adequate antidepressant treatments
Exclusion Criteria
* Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration
* Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
* Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
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
Research Site
Costa Mesa, California, United States
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Glendale, California, United States
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Orange, California, United States
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San Diego, California, United States
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Temecula, California, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Miami Springs, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Smyrna, Georgia, United States
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Chicago, Illinois, United States
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Oak Brook, Illinois, United States
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Lafayette, Indiana, United States
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Owensboro, Kentucky, United States
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Baltimore, Maryland, United States
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Haverhill, 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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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Fresh Meadows, New York, United States
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New York, 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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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
Salem, Oregon, 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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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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Witchita Falls, Texas, United States
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Charlottesville, Virginia, United States
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Herndon, Virginia, United States
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Bellevue, 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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Toronto, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Würzburg, Bavaria, Germany
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Stralsund, Mecklenburg-Vorpommern, Germany
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Bochum, North Rhine-Westphalia, Germany
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Achim, , Germany
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Research Site
Budapest, , Hungary
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Győr, , Hungary
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Bucharest, , Romania
Research Site
Lasi, , Romania
Research Site
Târgu Mureş, , Romania
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Moscow, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Chenigiv, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Poltava, , Ukraine
Countries
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References
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Kapadia S, Zhang Z, Ardic F, Patel M, Thase ME, Papakostas GI. Adjunctive brexpiprazole in patients with major depressive disorder who show minimal or partial response to antidepressant treatment: post hoc analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2025 Oct 7:pyaf074. doi: 10.1093/ijnp/pyaf074. Online ahead of print.
Ardic F, Zhang Z, Hogan M. Effects of adjunctive brexpiprazole in patients with major depressive disorder and sleep disturbance: a post hoc analysis of three randomized trials. Front Psychiatry. 2025 Aug 7;16:1618176. doi: 10.3389/fpsyt.2025.1618176. eCollection 2025.
Kapadia S, Zhang Z, Csoboth C, Patel M, Thase ME, Papakostas GI. Adjunctive brexpiprazole in patients with unresolved symptoms of depression on antidepressant treatment who are early in the disease course: post hoc analysis of randomized controlled trials. Int J Neuropsychopharmacol. 2025 Aug 1;28(8):pyaf050. doi: 10.1093/ijnp/pyaf050.
McIntyre RS, Bubolic S, Zhang Z, MacKenzie EM, Therrien F, Miguelez M, Boucher M. Effects of Adjunctive Brexpiprazole on Individual Depressive Symptoms and Functioning in Patients With Major Depressive Disorder and Anxious Distress: Post Hoc Analysis of Three Placebo-Controlled Studies. J Clin Psychopharmacol. 2024 Mar-Apr 01;44(2):133-140. doi: 10.1097/JCP.0000000000001825.
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.
McIntyre RS, Therrien F, Ismail Z, Meehan SR, Miguelez M, Larsen KG, Chen D, MacKenzie EM, Thase ME. Effects of adjunctive brexpiprazole on patient life engagement in major depressive disorder: Post hoc analysis of Inventory of Depressive Symptomatology Self-Report data. J Psychiatr Res. 2023 Jun;162:71-78. doi: 10.1016/j.jpsychires.2023.04.012. Epub 2023 Apr 12.
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.
McIntyre RS, Weiller E, Zhang P, Weiss C. Brexpiprazole as adjunctive treatment of major depressive disorder with anxious distress: Results from a post-hoc analysis of two randomised controlled trials. J Affect Disord. 2016 Sep 1;201:116-23. doi: 10.1016/j.jad.2016.05.013. Epub 2016 May 12.
Thase ME, Youakim JM, Skuban A, Hobart M, Zhang P, McQuade RD, Nyilas M, Carson WH, Sanchez R, Eriksson H. Adjunctive brexpiprazole 1 and 3 mg for patients with major depressive disorder following inadequate response to antidepressants: a phase 3, randomized, double-blind study. J Clin Psychiatry. 2015 Sep;76(9):1232-40. doi: 10.4088/JCP.14m09689.
Other Identifiers
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331-10-227
Identifier Type: -
Identifier Source: org_study_id
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