Comparison of the Effectiveness of Brexpiprazole With That of Risperidone

NCT ID: NCT02758067

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30

Brief Summary

To demonstrate that the effectiveness of brexpiprazole (2-4 mg/day) on quality of life is non-inferior to that of risperidone (4-6 mg/day) in adult patients with schizophrenia.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

brexpiprazole

Group Type: EXPERIMENTAL

brexpiprazole

Intervention Type: DRUG

2- 4 mg/day, tablets, oral, 28-weeks

risperidone

Group Type: EXPERIMENTAL

risperidone

Intervention Type: DRUG

4-6 mg/day, tablets, oral, 28-weeks

Interventions

brexpiprazole

2- 4 mg/day, tablets, oral, 28-weeks

Intervention Type: DRUG

risperidone

4-6 mg/day, tablets, oral, 28-weeks

Intervention Type: DRUG

Other Intervention Names

Rexulti (R)

Eligibility Criteria

Inclusion Criteria

• The patient has schizophrenia diagnosed according to DSM-5™
• The patient has his or her first formal diagnosis of schizophrenia less than 10 years ago
• The patient has been prescribed outpatient oral antipsychotic treatment at recommended dose range as stated in the Summary of product characteristics or equivalent document/label for the full 3 months prior to the Screening Visit.
• The patient has CGI-S score of 3 (mildly ill) or 4 (moderately ill) at the Screening and Baseline Visits.
• The patient has a Global Assessment Scale (GAS) score of 41 to 70 (limits included) at the Screening and Baseline Visits.
• The patient is in need of a change in the current antipsychotic treatment due to insufficient functional improvement and, in the judgement of the investigator, would benefit from a switch to another treatment. Reasons for switching include but are not limited to the following reasons:

1. lack of adequate response to his or her current antipsychotic medication,

2. poor tolerability to his or her current antipsychotic medication,

3. unwillingness of the patient to adhere to his or her current antipsychotic medication.

Exclusion Criteria

• The patient has a psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
• The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
• The patient is hospitalised for his or her psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
• The patient is treated with brexpiprazole, risperidone or clozapine at the time of Screening Visit.
• The patient has shown, in the investigator's judgment, significant lack of efficacy to brexpiprazole, risperidone or paliperidone when treated at recommended dose range as stated in their respective Summary of product characteristics or equivalent document/ label, in a manner that would preclude benefiting from the study medication if randomised to brexpiprazole or risperidone during the study.
• The patient is considered resistant to antipsychotic treatment according to the investigator's judgement.
• The patient is at significant risk of harming himself/herself, or others according to the investigator's judgement or based on the Columbia Suicide Severity Rating Scale (C-SSRS).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Other Identifiers

2015-001749-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16758A

Identifier Type: -

Identifier Source: org_study_id