Treatment-resistant Schizophrenia Clinical Trial
Official title:
Interventional, Randomized, Double-blind, Active-controlled Study of the Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)
In the study, patients will receive risperidone (4-6 mg/day), or, if recently failed on
risperidone, olanzapine (15-20mg/day). Later during the study, patients will be randomized to
either receive Lu AF35700 (10 mg/day), or continue their treatment from the prospective
confirmation (PC) period.
The study consists of a Screening Period (up to 3 weeks), a single-blind PC Period (6 weeks),
a Double-blind Treatment (DBT) Period (8 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Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn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 the 2 treatmetn arms (1:1) with either Lu AF35700 10
mg or to continue the treatment allocated in the PC period (olanzapine or risperidone) at the
dose set at the last visit of the PC period. This means that approximately half of the
confirmed treatment-resistant patients were randomised back to the failed treatment in the PC
period.
Data was not collected seperately for the DBT olanzapine and DBT risperidone participants,
and there was no intent to compare Lu AF35700 to each drug seperately.
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