Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (DayBreak)

Lundbeck

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Lu AF35700; Drug: Olanzapine; Drug: Risperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02717195

16159A

2014-003569-12 (EudraCT Number)

Details and patient eligibility

About

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

Full description

The study consists of a Screening Period (3 weeks), a single-blind Prospective Confirmation (PC) Period (6 weeks), a Double-blind Treatment (DBT) Period (10 weeks), and a Safety Follow-up Period (6 weeks).

Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.

Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period.

Data was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.

Enrollment: 1,098 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders
• The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.
• Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening
• The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)
• The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)
• The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

Exclusion criteria

• The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)
• The patient is experiencing an acute exacerbation of his/her psychotic symptoms
• The patient has not responded to treatment with clozapine

Other protocol defined inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,098 participants in 4 patient groups

Prospective Confirmation (PC) Period

Experimental group

Description:

Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks

Treatment:

Drug: Olanzapine

Drug: Risperidone

Double-blind Treatment (DBT) Period, Lu AF35700 10 mg

Experimental group

Description:

Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks

Treatment:

Drug: Lu AF35700

Drug: Lu AF35700

DBT Period, Lu AF35700 20 mg

Experimental group

Description:

Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks

Treatment:

Drug: Lu AF35700

Drug: Lu AF35700

DBT Period, Continued treatment from PC Period

Experimental group

Description:

Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period

Treatment:

Drug: Olanzapine

Drug: Risperidone