A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial 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
Sponsor study identifier
interventional
837
5 countries
47
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2016
Actual (reported)Study Completion
May 2016
Actual (reported)The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 18, 2014
Actual (reported)July 22, 2014
Actual (reported)April 2016
Actual (reported)May 2016
Actual (reported)August 21, 2018
Actual (reported)Change in the Montgomery-Asberg Depression
To assess the change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from Baseline (End of Phase A \[Week 8\]) to Week 14. The MADRS was utilized as the primary efficacy assessment of the participant's level of depression and was administered utilizing the Structured Interview Guide for the MADRS (SIGMA). The MADRS consisted of 10 items each with 7 defined grades of severity. The rater decided whether the rating lied on predefined scale steps (0, 2, 4, 6) or between them (1, 3, 5). The 10 items were apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score was 60; 0, no symptom; 60, severely affected.
From baseline (end of Phase A [Week 8]) to week 14
Change in the Sheehan Disability Scale (SDS) From Baseline to End of Treatment
From baseline (end of Phase A [Week 8]) to week 14
Brexpiprazole + ADT
Placebo + ADT
Placebo + ADT Placebo + FDA Approved Antidepressant (ADT)
Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
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 1;28(10):pyaf074. doi: 10.1093/ijnp/pyaf074.
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.
Claudette Brewer
Otsuka Pharmaceutical Development & Commercialization, Inc.
837 participants (actual enrollment reported by the registry).
First Submitted
July 18, 2014
First Posted
July 22, 2014
Study Start
July 2014
Date type not reportedThis date has not been verified as actual or estimated.
Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulation With <25% Improvement From Baseline of Phase A to End of Phase A in MADRS Total Score
From baseline (end of Phase A [Week 8]) to week 14
Change From End of Phase A to End of Phase B in MADRS Total Score for the Subpopulations With Anxious Distress as Specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).
From baseline (end of Phase A [Week 8]) to week 14
Contact the study team to confirm eligibility.
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
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.
Primary Completion
April 2016
Actual (reported)Study Completion
May 2016
Actual (reported)Last Updated
August 21, 2018
Results First Posted
August 21, 2018
Record last verified: 2018-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: