Clinical trial NCT02758067: Comparison of the Effectiveness of Brexpiprazole With That of Risperidone
Official title: Interventional, Randomised, Double-blind, Parallel-group, Active-comparator, Flexible-dose Study to Compare the Effectiveness of Brexpiprazole to That of Risperidone in Adult Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
Collaborators: name: Otsuka Pharmaceutical Co., Ltd.
First posted: 2016-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in Quality of life (QLS total score)
timeFrame: Baseline to Week 28
Secondary outcomes:
measure: Change in the 'Interpersonal Relations' QLS Domain Score
timeFrame: Baseline to Week 28
measure: Change in the 'Instrumental Role' QLS Domain Score
timeFrame: Baseline to Week 28
measure: Change in the 'Intrapsychic Foundations' QLS Domain Score
timeFrame: Baseline to Week 28
measure: Change in the 'Common Objects and Activities' QLS Domain Score
timeFrame: Baseline to Week 28
measure: Change in Global severity of illness (CGI-S)
timeFrame: Baseline to Week 28
measure: Investigator's Assessment Questionnaire (IAQ) Total Score
timeFrame: Baseline to Week 28
measure: Functional response (QLS total score)
timeFrame: at Week 28
measure: Readiness for Work Questionnaire (WoRQ)
timeFrame: Baseline to Week 28
measure: Work readiness status (from the WoRQ)
timeFrame: at Week 28
measure: Time to discontinuation
timeFrame: from Baseline to Week 28
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: