Safety and Tolerability Study of Lu AF11167 After Repeated Dosing in Patients With Schizophrenia

Inclusion Criteria:

- Man or woman aged ≥18 years and ≤60 years with a body mass index (BMI) of ≥18.5 and
≤38 m2

- Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20,
295.30, 295.90)

- Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at
the Screening Visit and Baseline Visit (Day -1)

- PANSS total score ≤80 at the Screening Visit and the Baseline Visit (Day -1)

- Score of 4 (moderate) of the following PANSS items at the Screening Visit and the
Baseline Visit (Day -1): P7 (hostility), G8 (uncooperativeness)

- Minimal level of extrapyramidal signs, defined as a score ≤5 (moderately severe) in
any of the four Clinical Global Impression of Severity (CGI-S) items of the ESRS-A;
parkinsonism, akathisia, dystonia, and tardive dyskinesia at the Screening Visit and
the Baseline Visit

- Willingness to be hospitalised for approximately 3 weeks after the Baseline Visit
(Day -1)

Exclusion Criteria:

- The patient experienced an acute exacerbation requiring hospitalization within the
last 6 months

- The patient experienced an acute exacerbation requiring increase in antipsychotic
medication (with reference to drug or dose) within the last 4 weeks

Other pre-defined inclusion and exclusion criteria may apply