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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01360632
First received: May 24, 2011
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
 Drug: OPC-34712 + ADT
Drug: Placebo + ADT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

Primary Outcome Measures:
  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score from randomization to the end of treatment [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Sheehan Disability Scale (SDS) from randomization to end of treatment [ Time Frame: Week 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1650
Study Start Date: June 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase B

Drug: OPC-34712 + ADT

Drug: Placebo + ADT

 Drug: OPC-34712 + ADT
Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
Drug: Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)
Placebo Comparator: Phase A
Drug: Placebo + ADT
 Drug: Placebo + ADT
Placebo + FDA Approved Antidepressant (ADT)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360632

  Show 71 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01360632     History of Changes
Other Study ID Numbers: 331-10-227
Study First Received: May 24, 2011
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Russia: Pharmacological Committee, Ministry of Health
Romania: Ministry of Public Health
Ukraine: Ministry of Health
Hungary: National Institute of Pharmacy

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Depression
Depressive Disorder
 Depressive Disorder, Major
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 17, 2013