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SchizophreniaPhase 3TAILWINDNCT02758067

Comparison of the Effectiveness of Brexpiprazole With That of Risperidone

A Phase 3 study testing brexpiprazole and risperidone in people with Schizophrenia, run by H. Lundbeck A/S.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
brexpiprazole and risperidone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2016to Jun 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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).

About this study

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

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
Being tested
brexpiprazole, risperidone
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • brexpiprazoleDrug

    Also called Rexulti (R)

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

  • risperidoneDrug

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

Study groups in NCT02758067
Study groupRoleWhat they receive
brexpiprazoleExperimentalNot described
Receives: Drug: brexpiprazole
risperidoneExperimentalNot described
Receives: Drug: risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline to Week 28

Secondary outcomes (10)

  1. 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

    Measured: Baseline to Week 28

  2. 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

    Measured: Baseline to Week 28

  3. 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

    Measured: Baseline to Week 28

  4. 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

    Measured: Baseline to Week 28

  5. 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).

    Measured: Baseline to Week 28

  6. 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

    Measured: Baseline to Week 28

  7. Functional response (QLS total score)

    Defined as change from Baseline in QLS total score of ≥10 points

    Measured: at Week 28

  8. 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

    Measured: Baseline to Week 28

  9. 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

    Measured: at Week 28

  10. Time to discontinuation

    Measured: from Baseline to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2016

Why it stopped: This study was withdrawn for administrative reasons. There were no safety concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758067
Sponsor's protocol ID
16758A
Other IDs
2015-001749-97, 2015
Acronym
TAILWIND
Status last verified
Jul 2016
First submitted
29 Apr 2016
Last updated
1 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing brexpiprazole and risperidone in people with Schizophrenia, run by H. Lundbeck A/S.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Quality of life (QLS total score) (time frame: Baseline to Week 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.

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