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Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia (EQUATOR)

This study has been completed.
Quintiles, Inc.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier:
First received: August 16, 2012
Last updated: July 20, 2015
Last verified: July 2015
The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.

Condition Intervention Phase
Acute Schizophrenia
Drug: Brexpiprazole
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) as Maintenance Treatment in Adults With Schizophrenia

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Outcome Measure: The primary efficacy endpoint of this trial is the time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase C. [ Time Frame: From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Outcome Measure: the percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria [ Time Frame: randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 524
Study Start Date: October 2012
Study Completion Date: February 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo comparator for 52 weeks
Drug: Placebo
Placebo comparator for 52 weeks
Experimental: Brexpiprazole (OPC-34712)
Brexpiprazole (OPC-34712) for 52 weeks
Drug: Brexpiprazole
Brexpiprazole tablets 1 to 4 mg /day

Detailed Description:
Schizophrenia is a severely debilitating mental illness that affects approximately 1% of the world population. Hallucinations and delusions are the most striking characteristic positive symptoms of schizophrenia; however, more subtle negative symptoms (eg, social withdrawal and lack of emotion, energy, and motivation) may also be present. The first antipsychotics developed for the treatment of schizophrenia were effective against positive symptoms, but showed little efficacy for negative symptoms and were also associated with a high incidence of side effects. Second generation antipsychotics, represent a significant advancement in the treatment of psychotic disorders because they are effective and at the same time exhibit fewer side effects than first generation antipsychotics. Although generally safer than first generation antipsychotics, the second-generation antipsychotics are not devoid of undesirable side effects such as Hyperprolactinemia and weight gain. In addition, the safety of these drugs vary considerably.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients age 18 years or older to less than 65 years, inclusive (at time of informed consent)
  • Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria and a history of the illness for at least three years prior to screening (as per subject, family, healthcare provider, or by previous medical records).
  • Subjects with a stable living environment, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
  • Subjects who showed previous response to antipsychotic treatment in the past year.
  • Subjects who are currently treated with oral or depot antipsychotics other than clozapine or who have had a recent lapse in antipsychotic treatment requiring chronic treatment with antipsychotic medication for stabilization.
  • Subjects who are experiencing a current acute exacerbation of psychotic symptoms requiring stabilization
  • Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

  • Female patients who are breastfeeding or who have a positive pregnancy test (urine) result prior to receiving investigational medicinal product
  • Patients presenting a first episode of schizophrenia based on the clinical judgment of the investigator
  • Patients who are diagnosed with a disease other than schizophrenia (schizoaffective disorder, major depressive disorder, bipolar disorder, posttraumatic stress disorder, anxiety disorder, delirium, dementia, amnesia, or other cognitive disorder) based on current DSM-IV-TR Axis Ι criteria, or who are diagnosed with a personality disorder (borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial)
  • Subjects experiencing acute depressive symptoms within the past 30 days
  • Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history
  • Subjects with a significant risk of violent behavior; who represent a risk of committing suicide
  • Subjects with clinically significant tardive dyskinesia
  • Subjects currently treated with insulin for diabetes.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01668797

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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Quintiles, Inc.
Study Director: Aleksandar Skuban, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
  More Information

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc. Identifier: NCT01668797     History of Changes
Other Study ID Numbers: 331-10-232  2011-005766-38 
Study First Received: August 16, 2012
Last Updated: July 20, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents processed this record on December 08, 2016