Pyxis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Fixed Dose OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Pyxis Trial
Sponsor study identifier
interventional
826
5 countries
57
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
June 2013
Actual (reported)To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2013
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.
May 24, 2011
Actual (reported)May 25, 2011
Actual (reported)July 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)June 2013
Actual (reported)November 26, 2015
Actual (reported)Change From Baseline (End of Phase A [Week 8]) to Week 14 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score for the Efficacy Sample.
The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Baseline and Week 14
Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score for the Efficacy Sample Per the Final Protocol.
The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the "best" rating and 6 being the "worst" rating. The MADRS total score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60. The MADRS total score will be un-evaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items are recorded, the MADRS total score will be the mean of the recorded items multiplied by 10 and then rounded to the first decimal place.
Drug: OPC-34712 + ADT Drug: Placebo + ADT
Intervention: Drug: Placebo + ADT
Tablet, Oral, 2 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
Placebo + FDA Approved Antidepressant (ADT)
Research Site
Arcadia, California, United States
Research Site
Beverly Hills, California, United States
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Fresno, California, United States
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Oceanside, 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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Sherman Oaks, California, 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.
826 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2011
First Posted
May 25, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Baseline and Week 14
Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in Sheehan Disability Scale (SDS) Score for the Efficacy Sample.
Baseline and Week 14
Mean Change From Baseline (End of Phase A [Week 8]) to Week 14 in SDS Score for the Efficacy Sample Per the Final Protocol
Baseline and Week 14
Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample.
Week 9, 10, 11, 12, and 13
Change From Baseline (End of Phase A [Week 8]) to Week 14 in MADRS Total Score by Trial Week for the Efficacy Sample Per the Final Protocol.
Week 9, 10, 11, 12, and 13
Mean Clinical Global Impression-Improvement (CGI-I) Scale Score (End of Phase A [Week 8]) to Week 14 by Trial Week for the Efficacy Sample.
Week 9, 10, 11, 12, 13, and 14
Placebo + FDA Approved Antidepressant (ADT)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Research Site
Denver, Colorado, United States
Research Site
Norwalk, Connecticut, United States
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Coral Springs, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Orlando, Florida, United States
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Indianapolis, Indiana, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Belmont, Massachusetts, United States
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Boston, Massachusetts, United States
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Lincoln, Nebraska, 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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Dayton, Ohio, United States
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Toledo, Ohio, 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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Philadelphia, Pennsylvania, United States
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San Antonio, Texas, United States
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Murray, Utah, United States
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Woodstock, Vermont, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Penticton, British Columbia, Canada
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Toronto, Ontario, Canada
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Gatineau, Quebec, Canada
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Arcachon, France
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Élancourt, France
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Orvault, France
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Palaiseau, France
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Toulouse, France
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Bełchatów, Poland, Poland
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Katowice, Upper Silesia, Poland
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Poznan, Woj. Wielkopolskie, Poland
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Gdynia, Poland
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Kielce, Poland
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Lublin, Poland
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Tuszyn, Poland
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Warsaw, Poland
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Kosice-Barca, Slovakia, Slovakia
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Bratislava, Slovakia
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Levice, Slovakia
Research Site
Michalovce, 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.
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, Augustine C, Zhang P, McQuade RD, Carson WH, Nyilas M, Sanchez R, Eriksson H. Efficacy and safety of adjunctive brexpiprazole 2 mg in major depressive disorder: a phase 3, randomized, placebo-controlled study in patients with inadequate response to antidepressants. J Clin Psychiatry. 2015 Sep;76(9):1224-31. doi: 10.4088/JCP.14m09688.
Primary Completion
May 2013
Actual (reported)Study Completion
June 2013
Actual (reported)Last Updated
November 26, 2015
Results First Posted
November 26, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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