Trials Sponsors Conditions Drugs Pricing

Conditions

Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Keywords

OPC-34712brexpiprazoleMajor Depressive DisorderAdjunctive 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.

Study Arms (2)

Phase B

EXPERIMENTAL

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

Drug: OPC-34712 + ADTDrug: Placebo + ADT

Phase A

PLACEBO COMPARATOR

Drug: Placebo + ADT

Interventions

OPC-34712 + ADTDrug

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

Phase B

Placebo + ADTDrug

Placebo + FDA Approved Antidepressant (ADT)

Phase B

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Otsuka Pharmaceutical Development & Commercialization, Inc.
Industrylead

Study Sites (71)

Research Site

Birmingham, Alabama, United States

Research Site

Costa Mesa, California, United States

Research Site

Glendale, California, United States

Research Site

Orange, California, United States

Research Site

San Diego, California, United States

Research Site

Temecula, California, United States

Research Site

Jacksonville, Florida, United States

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: 41055581DERIVED
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: 40852147DERIVED

MeSH Terms

Conditions

Depressive DisorderDepressionDepressive Disorder, MajorMood DisordersMental Disorders

Interventions

Androgen Antagonists

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Hormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic Actions

Results Point of Contact

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

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

1,539 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

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)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Phase B

Phase A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (71)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (22)

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Phase B

Phase A

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (71)

Related Publications (10)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (22)

You may not qualify if:

Source record

Locations