Comparison of the Effectiveness of Brexpiprazole With That of Risperidone (TAILWIND)

Lundbeck

Status and phase

Withdrawn

Phase 3

Conditions

Schizophrenia

Treatments

Drug: brexpiprazole

Drug: risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02758067

16758A

2015-001749-97 (EudraCT Number)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).