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

(EQUATOR Trial)

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Eligibility 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).

Treatment Details

Interventions

• Brexpiprazole (Atypical Antipsychotic)
• Placebo (Other)

Participant Groups

Group I: Brexpiprazole (OPC-34712) Experimental Treatment 1 Intervention

Brexpiprazole (OPC-34712) for 52 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo comparator for 52 weeks

Brexpiprazole is already approved in United States, Canada, European Union, Japan, Australia, Brazil for the following indications:

🇺🇸 Approved in United States as Rexulti for:

• Major depressive disorder (as an adjunctive therapy to antidepressants)
• Schizophrenia
• Agitation associated with dementia due to Alzheimer's disease

🇨🇦 Approved in Canada as Rexulti for:

• Major depressive disorder (as an adjunctive therapy to antidepressants)
• Schizophrenia

🇪🇺 Approved in European Union as Rexulti for:

• Schizophrenia

🇯🇵 Approved in Japan as Rexulti for:

• Schizophrenia

🇦🇺 Approved in Australia as Rexulti for:

• Schizophrenia

🇧🇷 Approved in Brazil as Rexulti for:

• Major depressive disorder (as an adjunctive therapy to antidepressants)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NCT01668797 Las Vegas, NV

NCT01668797 Garden Grove, CA

NCT01668797 Memphis, TN

NCT01668797 Dallas, TX

More Trial Locations

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc. Lead Sponsor

Quintiles, Inc. Industry Sponsor

References