Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

The study includes 2 treatment periods. The open-label run-in period will begin at patient
enrolment and continue for 3 weeks, during which all patients will receive once daily
treatment with zicronapine. The double-blind period will begin at patient randomization and
continue for 5 weeks, during which the patients will be assigned to one group receiving once
daily treatment with zicronapine and 3 groups receiving once weekly treatment with
zicronapine.

Inclusion Criteria:

- Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of
Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)

- A score of <=4 (moderately ill) on Clinical Global Impression - Severity of Illness
(CGI-S) scale

- A total score >=60 on Positive and Negative Syndrome Scale (PANSS)

- A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)

Exclusion Criteria:

- Acute exacerbation requiring hospitalization within the last 3 months OR requiring
change of antipsychotic medication within the last 4 weeks

- Diagnosis or history of substance dependence or substance abuse according to
DSM-IV-TR within the last 3 months

- Significant risk of harming himself/herself or others

- Positive serology for hepatitis A, B, C, or HIV

- Present condition that might compromise liver function

- Medical or neurological disorder or treatment that could interfere with study
treatment or compliance

- Previous exposure to zicronapine

Other inclusion and exclusion criteria may apply.