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

Recruiting in Palo Alto (17 mi)

+146 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: H. Lundbeck A/S

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

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

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Treatment Details

Interventions

Lu AF35700 (Unknown)

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Prospective Confirmation (PC) PeriodExperimental Treatment2 Interventions

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

Group II: Double-blind Treatment (DBT) Period, Lu AF35700 10 mgExperimental Treatment1 Intervention

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

Group III: DBT Period, Lu AF35700 20 mgExperimental Treatment1 Intervention

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

Group IV: DBT Period, Continued treatment from PC PeriodExperimental Treatment2 Interventions

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