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

This study is currently recruiting participants.
Verified April 2013 by Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01668797
First received: August 16, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 420
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668797

Contacts
Contact: Compass Schizophrenia compass.schizophrenia@quintiles.com

  Show 68 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Quintiles
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01668797     History of Changes
Other Study ID Numbers: 331-10-232, 2011-005766-38
Study First Received: August 16, 2012
Last Updated: April 10, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013