Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
NCT ID: NCT02196506
Last Updated: 2018-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
837 participants
INTERVENTIONAL
2014-07-31
2016-05-31
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
QUADRUPLE
Study Groups
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Brexpiprazole + ADT
Brexpiprazole + ADT
Brexpiprazole +ADT
Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
Placebo + ADT
Placebo + ADT
Placebo + ADT
Placebo + ADT Placebo + FDA Approved Antidepressant (ADT)
Interventions
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Placebo + ADT
Placebo + ADT Placebo + FDA Approved Antidepressant (ADT)
Brexpiprazole +ADT
Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
Eligibility Criteria
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Inclusion Criteria
* Current depressive episode must be at least 8 weeks in duration
Exclusion Criteria
* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode
* Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder, Bipolar I or II disorder
18 Years
65 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Claudette Brewer
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
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Birmingham, Alabama, United States
Beverly Hills, California, United States
Denver, Colorado, United States
Hialeah, Florida, United States
Orlando, Florida, United States
Alpharetta, Georgia, United States
Smyrna, Georgia, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Rochester Hills, Michigan, United States
Cherry Hill, New Jersey, United States
Jamaica, New York, United States
New York, New York, United States
Staten Island, New York, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
Portland, Oregon, United States
Salem, Oregon, United States
Philadelphia, Pennsylvania, United States
Lincoln, Rhode Island, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Wichita Falls, Texas, United States
Murray, Utah, United States
Woodstock, Vermont, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Achim, , Germany
Berlin, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Oranienburg, , Germany
Stralsund, , Germany
Würzburg, , Germany
Budapest, , Hungary
Győr, , Hungary
Gdansk, , Poland
Lubin, , Poland
Sosnowiec, , Poland
Warsaw, , Poland
Bratislava, , Slovakia
Kosice-Barca, , Slovakia
Liptovský Mikuláš, , Slovakia
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.
Hobart M, Skuban A, Zhang P, Augustine C, Brewer C, Hefting N, Sanchez R, McQuade RD. A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Fixed-Dose Brexpiprazole 2 mg/d as Adjunctive Treatment of Adults With Major Depressive Disorder. J Clin Psychiatry. 2018 May 22;79(4):17m12058. doi: 10.4088/JCP.17m12058.
Other Identifiers
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331-13-214
Identifier Type: -
Identifier Source: org_study_id
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