Clinical trial NCT01360632: 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)
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Keywords: OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 1539
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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
timeFrame: Baseline and Week 14
measure: Mean Change in MADRS Total Score From Baseline End of Week 8 to Week 14 for the Efficacy Sample Per Final Protocol
timeFrame: Baseline and Week 14
Secondary outcomes:
measure: 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
timeFrame: Week 8, 9, 10, 11, 12, and 13
measure: 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
timeFrame: Week 8, 9, 10, 11, 12, and 13
measure: 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
timeFrame: Week 11 and Week 14
measure: 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
timeFrame: Week 11 and Week 14
measure: Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set
timeFrame: Week 11 and Week 14
measure: Change From Baseline (End of Phase A [Week 8]) in SDS Item Scores for the Efficacy Sample Set Per Final Protocol
timeFrame: Week 11 and Week 14
measure: Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical Global Impression Severity of Illness (CGI-S) for the Efficacy Sample Set
timeFrame: Weeks 8, 9, 10, 11, 12,13 and 14
measure: Mean Change From End of Phase A (Week 8 Visit) to Phase B by Study Week in Clinical CGI-S for the Efficacy Sample Per Final Protocol
timeFrame: Weeks 8, 9, 10, 11, 12, 13, and 14
measure: Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) IDS-SR Total Score for the Efficacy Sample Set
timeFrame: Weeks 8, 9, 10, 11, 12, 13, and 14
measure: Mean Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in IDS-SR Total Score for the Efficacy Sample Per Final Protocol
timeFrame: Weeks 8, 9, 10, 11, 12, 13, and 14
measure: Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) Hamilton Depression Scale 17 Item Version (HAM)-D17 Total Score for the Efficacy Sample Set
timeFrame: Baseline and Week 14
measure: Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-D17 Total Score for the Efficacy Sample Set Per Final Protocol
timeFrame: Baseline and Week 14
measure: Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Anxiety Rating Scale (HAM-A) Total Score for the Efficacy Sample Set
timeFrame: Baseline and Week 14
measure: Mean Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in HAM-A Total for the Efficacy Sample Per Final Protocol
timeFrame: Baseline and Week 14
measure: Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Set
timeFrame: Week 8 to Week 14
measure: Mean CGI-I Score at Each Trial Week Visit in Phase B for the Efficacy Sample Per Final Protocol
timeFrame: Weeks 8, 9, 10, 11, 12, 13, and 14
measure: Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set
timeFrame: Weeks 8, 9, 10, 11, 12, 13, and 14
measure: Percentage of Participants With a MADRS Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol
timeFrame: Weeks 8, 9, 10, 11, 12, 13, and 14
measure: Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Set
timeFrame: Weeks 8, 9, 10, 11, 12, 13 and 14
measure: Percentage of Participants With a MADRS Remission During Phase B Relative to the End of Phase A (Week 8) for the Efficacy Sample Per Final Protocol
timeFrame: Weeks 8, 9, 10, 11, 12, 13 and 14
measure: Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Set
timeFrame: Weeks 8, 9, 10, 11, 12, 13 and 14
measure: Percentage of Participants With a CGI-I Response During Phase B Relative to the End of Phase A (Week 8 Visit) for the Efficacy Sample Per Final Protocol
timeFrame: Weeks, 8, 9, 10, 11, 12, 13, and 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Costa Mesa
country: United States
facility: Research Site
state: California
city: Glendale
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
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state: California
city: Temecula
country: United States
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state: California
city: Jacksonville Beach
country: United States
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state: Florida
city: Jacksonville
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state: Florida
city: Miami Springs
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state: Florida
city: Tampa
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state: Florida
city: Winter Park
country: United States
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state: Florida
city: Atlanta
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state: Georgia
city: Smyrna
country: United States
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state: Georgia
city: Chicago
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state: Illinois
city: Oak Brook
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state: Illinois
city: Lafayette
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state: Indiana
city: Owensboro
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state: Kentucky
city: Baltimore
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state: Maryland
city: Haverhill
country: United States
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state: Massachusetts
city: Weymouth
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state: Massachusetts
city: Rochester Hills
country: United States
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state: Michigan
city: Creve Coeur
country: United States
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state: Missouri
city: Las Vegas
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state: Nevada
city: Cherry Hill
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state: New Jersey
city: Toms River
country: United States
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state: New Jersey
city: Brooklyn
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state: New York
city: Fresh Meadows
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Staten Island
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
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state: North Carolina
city: Beachwood
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Portland
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state: Oregon
city: Salem
country: United States
state: Oregon
city: Norristown
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Lincoln
country: United States
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state: Rhode Island
city: Columbia
country: United States
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state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Witchita Falls
country: United States
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state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Herndon
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Brown Deer
country: United States
facility: Research Site
state: Wisconsin
city: Middleton
country: United States
facility: Research Site
state: Wisconsin
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: Research Site
state: Quebec
city: Wurzburg
country: Germany
facility: Research Site
state: Bavaria
city: Stralsund
country: Germany
facility: Research Site
state: Mecklenburg-Vorpommern
city: Bochum
country: Germany
facility: Research Site
state: NRW
city: Achim
country: Germany
facility: Research Site
city: Nyiregyhaza
country: Hungary
facility: Research Site
state: Szabolcs Szatmar Bereg
city: Budapest
country: Hungary
facility: Research Site
city: Gyor
country: Hungary
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Lasi
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Rostov on Don
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Chenigiv
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.