Back to resultsComparison of the Effectiveness of Brexpiprazole With That of Risperidone (TAILWIND)
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
brexpiprazole
risperidone
Sponsored by
About this trial
This is an interventional treatment trial for 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:
- 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.
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
brexpiprazole
risperidone
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in the 'Interpersonal Relations' QLS Domain Score
The Interpersonal Relations domain score is the sum of 8 items (numbers 1 to 8). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning), giving a range of 0 to 48, where the higher score indicates normal or unimpaired functioning
Change in the 'Instrumental Role' QLS Domain Score
The Instrumental Role domain score is calculated as the sum of 4 items (numbers 9 to 12). Each item is rated on a 7-point scale, from 0 (severe where the higher score indicates normal or unimpaired functioning
Change in the 'Intrapsychic Foundations' QLS Domain Score
The Intrapsychic Foundations domain score is calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning), giving a range of 0 to 42, where the higher score indicates normal or unimpaired functioning
Change in the 'Common Objects and Activities' QLS Domain Score
The Common Objects and Activities score is calculated as the sum of 2 items (numbers 18 and 19). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning), giving a range of 0 to 12, where the higher score indicates normal or unimpaired functioning
Change in Global severity of illness (CGI-S)
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Investigator's Assessment Questionnaire (IAQ) Total Score
The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, extrapyramidal symptoms (EPS) (other than akathisia) and other safety or tolerability issues. For each item, the current medication is compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable
Functional response (QLS total score)
Defined as change from Baseline in QLS total score of ≥10 points
Readiness for Work Questionnaire (WoRQ)
The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ total score is based on 7 statements. The statements is rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree'. Lower WoRQ total scores indicate better functioning
Work readiness status (from the WoRQ)
The work readiness status is assessed by the clinician. The 7 statements from WoRQ are used to aid in reaching the dichotomous work readiness judgment where the clinician must indicate (yes or no) if the patient is ready for work or not
Time to discontinuation
Full Information
NCT ID
NCT02758067
First Posted
April 29, 2016
Last Updated
July 29, 2016
Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02758067
Brief Title
Comparison of the Effectiveness of Brexpiprazole With That of Risperidone
Acronym
TAILWIND
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
This study was withdrawn for administrative reasons. There were no safety concerns.
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
Collaborators
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brexpiprazole
Arm Type
Experimental
Arm Title
risperidone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
brexpiprazole
Other Intervention Name(s)
Rexulti (R)
Intervention Description
2- 4 mg/day, tablets, oral, 28-weeks
Intervention Type
Drug
Intervention Name(s)
risperidone
Intervention Description
4-6 mg/day, tablets, oral, 28-weeks
Primary Outcome Measure Information:
Title
Change in Quality of life (QLS total score)
Description
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
Time Frame
Baseline to Week 28
Secondary Outcome Measure Information:
Title
Change in the 'Interpersonal Relations' QLS Domain Score
Description
The Interpersonal Relations domain score is the sum of 8 items (numbers 1 to 8). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning), giving a range of 0 to 48, where the higher score indicates normal or unimpaired functioning
Time Frame
Baseline to Week 28
Title
Change in the 'Instrumental Role' QLS Domain Score
Description
The Instrumental Role domain score is calculated as the sum of 4 items (numbers 9 to 12). Each item is rated on a 7-point scale, from 0 (severe where the higher score indicates normal or unimpaired functioning
Time Frame
Baseline to Week 28
Title
Change in the 'Intrapsychic Foundations' QLS Domain Score
Description
The Intrapsychic Foundations domain score is calculated as the sum of 7 items (numbers 13 to 17 and 20 and 21). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning), giving a range of 0 to 42, where the higher score indicates normal or unimpaired functioning
Time Frame
Baseline to Week 28
Title
Change in the 'Common Objects and Activities' QLS Domain Score
Description
The Common Objects and Activities score is calculated as the sum of 2 items (numbers 18 and 19). Each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning), giving a range of 0 to 12, where the higher score indicates normal or unimpaired functioning
Time Frame
Baseline to Week 28
Title
Change in Global severity of illness (CGI-S)
Description
Clinical Global Impression - Severity of Illness (CGI-S) score provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time Frame
Baseline to Week 28
Title
Investigator's Assessment Questionnaire (IAQ) Total Score
Description
The IAQ is a clinician-rated scale designed to assess the relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. The IAQ consists of 12 items: positive symptoms, negative symptoms, other efficacy symptoms, cognition, energy, mood, somnolence, weight gain, signs and symptoms of prolactin elevation, akathisia, extrapyramidal symptoms (EPS) (other than akathisia) and other safety or tolerability issues. For each item, the current medication is compared with previous antipsychotic medication on a five-point scale from 1 (Much better) to 5 (Much worse), or that item is Not applicable
Time Frame
Baseline to Week 28
Title
Functional response (QLS total score)
Description
Defined as change from Baseline in QLS total score of ≥10 points
Time Frame
at Week 28
Title
Readiness for Work Questionnaire (WoRQ)
Description
The Readiness for Work Questionnaire (WoRQ) is a clinician-rated scale designed to measure a schizophrenic patient's ability to work. The WoRQ total score is based on 7 statements. The statements is rated on a four-point scale, from 'strongly agree', 'agree', 'disagree' or 'strongly disagree'. Lower WoRQ total scores indicate better functioning
Time Frame
Baseline to Week 28
Title
Work readiness status (from the WoRQ)
Description
The work readiness status is assessed by the clinician. The 7 statements from WoRQ are used to aid in reaching the dichotomous work readiness judgment where the clinician must indicate (yes or no) if the patient is ready for work or not
Time Frame
at Week 28
Title
Time to discontinuation
Time Frame
from Baseline to Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
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.
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Effectiveness of Brexpiprazole With That of Risperidone
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