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)

NCT01360632 | Completed Phase 3 Results

• 1 other identifier: 331-10-227
• Study Type: interventional
• Target: 1,539
• Locations: 7 countries
• Sites: 71

Brief Summary

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

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders

Keywords

OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment

Outcome Measures

Primary Outcomes (2)

• Mean Change From the End of Phase A (Week 8 Visit) to Phase B (Week 14 Visit) in the Montgomery-Asberg Depression Rating Scale for the Efficacy Sample Set

  The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted 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 were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.

  Baseline and Week 14

• Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol

  The MADRS was utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consisted 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 were to be unevaluable if less than 8 of the 10 items were recorded. If 8 or 9 of the 10 items were recorded, the MADRS total score was the mean of the recorded items multiplied by 10 and then rounded of to the first decimal place. The MADRS Total Score is the sum of ratings for all 10 items. The possible total scores are from 0 to 60, with higher values indicating worse outcome.

  Baseline and Week 14

Secondary Outcomes (22)

• Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Set

  Week 8, 9, 10, 11, 12, and 13

• Mean Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than Week 14 Visit for the Efficacy Sample Per Final Protocol

  Week 8, 9, 10, 11, 12, and 13

• Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Scores for the Efficacy Sample Set

  Week 11 and Week 14

• Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in SDS Mean Scores for the Efficacy Sample Per Final Protocol

  Week 11 and Week 14

• Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set

  Week 11 and Week 14

Study Arms (2)

Phase B

EXPERIMENTAL

Drug: OPC-34712 + ADT Drug: Placebo + ADT

Drug: OPC-34712 + ADT; Drug: Placebo + ADT

Phase A

PLACEBO COMPARATOR

Drug: Placebo + ADT

Drug: Placebo + ADT

Interventions

OPC-34712 + ADT DRUG

Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)

Phase B

Placebo + ADT DRUG

Placebo + FDA Approved Antidepressant (ADT)

Phase B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 65 years of age, with diagnosis of major depressive disorder, as defined by DSM-IV-TR 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

You may not qualify if:

• Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug
• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (71)

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Birmingham, Alabama, United States

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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

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Unknown Facility

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

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Budapest, Hungary

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Győr, Hungary

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Bucharest, Romania

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Lasi, Romania

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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

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Related Publications (10)

• 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.

  PMID: 41055581 DERIVED

• 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.

  PMID: 40852147 DERIVED

• 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.

  PMID: 40607746 DERIVED

• 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.

  PMID: 38421922 DERIVED

• 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.

  PMID: 37656180 DERIVED

• 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.

  PMID: 37099968 DERIVED

• 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.

  PMID: 31577867 DERIVED

• 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.

  PMID: 30508090 DERIVED

• 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.

  PMID: 27208498 DERIVED

• 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.

  PMID: 26301771 DERIVED

MeSH Terms

Conditions

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 25, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 1, 2016
• Results First Posted: January 1, 2016

Record last verified: 2015-11

Locations

DE (4); RU (3); CA (2); UA (4); HU (3); US (52); RO (3)