Safety and Tolerability of BI 409306 in Patients With Schizophrenia

Inclusion criteria:

1. Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical
Manual of Mental Disorders (DSM-IV)) with the following clinical features:

1. Clinically stable and are in the residual (non-acute) phase of their illness for
at least 8 weeks.

2. Maintained on current antipsychotic medications and current dose for at least 8
weeks.

3. Have no more than a moderate severity rating on hallucinations and delusions
(e.g. Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual
Thought Content item score < or =4).

4. Have no more than a moderate severity rating on positive formal thought disorder
(e.g. BPRS Conceptual Disorganization item score < or =4).

5. Have no more than a moderate severity rating on negative symptoms (Positive and
Negative Syndrome Scale negative syndrome total score <15).

6. Have a minimal level of extrapyramidal symptoms (e.g. Simpson-Angus Scale total
score < 6) and depressive symptoms (e.g. Calgary Depression Scale total score <
10).

2. Male or female patients age > or = 18 and < or =55 years.

3. Patients must exhibit reliability and physiologic capability to comply with all
protocol procedures.

4. Signed and dated written informed consent prior to admission to the study in
accordance with GCP and the local legislation. If the patient needs a legal
representative, then this legal representative must give written consent as well.

Exclusion criteria:

1. Patient treated with more than one antipsychotic or not stabilized on antipsychotic
treatment, or having had electroconvulsive therapy within the last 30 days

2. Patient's cognitive impairment severity compromises the validity of the cognitive
outcome measures, in the clinical judgment of the investigator.

3. Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt,
aborted attempt, or preparatory acts or behavior).

4. Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale
(C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without
specific plan, or active suicidal thought with plan and intent).

5. Any finding of the medical examination (including BP, PR and ECG) or laboratory value
deviating from normal and of clinical relevance in the judgment of the investigator.

6. Any evidence of a clinically relevant concomitant disease.

7. History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal,
hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological
or hormonal disorders.

8. Female patients that are of child-bearing potential or currently breastfeeding.

9. Known history, or new diagnosis per screening labs, of HIV infection.

10. History of neurologic (e.g. stroke, seizure without a clear and resolved etiology,
concussion accompanying loss of consciousness) or psychiatric condition that the
investigator deems may interfere with interpretability of data

11. History of malignancy within the last 5 years, except for basal cell carcinoma.

12. Planned elective surgery requiring general anaesthesia, or hospitalisation for more
than 1 day during the study period.

13. Any other clinical condition that, in the opinion of the investigator, would
jeopardize a patient's safety while participating in this clinical trial.

14. Significant history of drug dependence or abuse (including alcohol, as defined in
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or in the opinion of
the investigator) within the last two years prior to informed consent, or a positive
urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana
at screening.

15. Participation in another trial with an investigational drug or procedure within 30
days prior to screening or previous participation in any BI 409306 study.