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

Acute Schizophrenia Clinical Trial

— EQUATOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668797
• Other study ID #: 331-10-232
• Secondary ID: 2011-005766-38
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2012
• Last updated: July 20, 2015
• Start date: October 2012
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of brexpiprazole compared with placebo as maintenance treatment in adults with schizophrenia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 ? 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.

Study Design

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

Related Conditions & MeSH terms

• Acute Schizophrenia
• Schizophrenia

Intervention

Drug:
• Brexpiprazole
Brexpiprazole tablets 1 to 4 mg /day
• Placebo
Placebo comparator for 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.	Quintiles, Inc.

Countries where clinical trial is conducted

United States,  Colombia,  Malaysia,  Puerto Rico,  Romania,  Serbia,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome Measure: The primary efficacy endpoint of this trial is the time from randomization to exacerbation of psychotic symptoms/impending relapse in Phase C.		From randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks	No
Secondary	Outcome Measure: the percentage of subjects meeting exacerbation of psychotic symptoms/impending relapse criteria		randomization to time of exacerbation of psychotic symptoms/impending relapse - up to 52 weeks	No