Comparison of the Effectiveness of Brexpiprazole With That of Risperidone

NCT02758067 | Withdrawn Phase 3

• 2 other identifiers: 16758A2015-001749-97
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Change in Quality of life (QLS total score)

  Evaluated by non-inferiority followed by superiority if non-inferiority is confirmed. The Quality of Life Scale (QLS) is a clinician-rated scale designed to assess deficit symptoms of schizophrenia and functioning during the preceding 4 weeks. The QLS consists of 21 items in 4 domains: Interpersonal Relations (eight items), Instrumental Role (four items), Intrapsychic Foundations (seven items), and Common Objects and Activities (two items). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). Definitions are provided for 4 anchor points of the 7 points. Each item has a brief description of the judgement to be made and a set of suggested probes for the clinician. The total score is calculated as the sum of all 21 items giving a range of 0 to 126, where the higher score indicates normal or unimpaired functioning

  Baseline to Week 28

Secondary Outcomes (10)

• Change in the 'Interpersonal Relations' QLS Domain Score

  Baseline to Week 28

• Change in the 'Instrumental Role' QLS Domain Score

  Baseline to Week 28

• Change in the 'Intrapsychic Foundations' QLS Domain Score

  Baseline to Week 28

• Change in the 'Common Objects and Activities' QLS Domain Score

  Baseline to Week 28

• Change in Global severity of illness (CGI-S)

  Baseline to Week 28

Study Arms (2)

brexpiprazole

EXPERIMENTAL

Drug: brexpiprazole

risperidone

EXPERIMENTAL

Drug: risperidone

Interventions

brexpiprazole DRUG

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

Also known as: Rexulti (R)

brexpiprazole

risperidone DRUG

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

risperidone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• lack of adequate response to his or her current antipsychotic medication,
• poor tolerability to his or her current antipsychotic medication,
• unwillingness of the patient to adhere to his or her current antipsychotic medication.

You may not qualify if:

• 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).

Sponsors & Collaborators

• H. Lundbeck A/S: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 2, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Last Updated: August 1, 2016

Record last verified: 2016-07