Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

Inclusion criteria:

- Men or women who are 18-50 years (inclusive) of age at time of consent

- Established schizophrenia with the following clinical features:

- Outpatient, with no hospitalization for worsening of schizophrenia within 3
months prior to randomisation

- Medically stable over the prior 4 weeks and psychiatrically stable without
symptom exacerbation within 3 months prior to randomisation

- patients who have no more than a moderate severe rating on the Positive and
Negative Symptom Scale (PANSS) positive items P1, P3-P7 and no more than a
moderate rating on the PANSS positive item P2

- Current antipsychotic and concomitant psychotropic medications as assessed at Visit 1
must meet the criteria below:

- patients may have up to 2 antipsychotics (typical and/or atypical)

- patients must be maintained on current typical and/or atypical antipsychotics
other than Clozapine and on current dose for at least 4 weeks prior to
randomisation and/or maintained on current long acting injectable antipsychotics
and current dose for at least 3 months prior to randomization

- patients must be maintained on current concomitant psychotropic medications,
anticholinergics, antiepileptics and/or lithium for at least 3 months prior to
randomisation and on current dose for at least 4 weeks prior to randomisation

- Women of child-bearing potential must be ready and able to use highly effective
methods of birth control that result in a low failure rate of less than 1% per year
when used consistently and correctly.

- Patients must exhibit reliability, physiologic capability, and an educational level
sufficient to comply with all protocol procedures, in the investigator´s opinion

- Patients must have an identified informant who will be consistent throughout the
study.

- Further inclusion criteria apply

Exclusion criteria:

- Patients who have a categorical diagnosis of another current major psychiatric
disorder

- Diseases of the central nervous system that may impact cognitive test performance

- Movement disorder not currently controlled

- Patients receiving another investigational drug or procedure within 30 days or 6
half-lives (whichever is longer) or recent participation in another trial with any
cognitive enhancing therapy

- Recent participation in formal cognitive remediation program

- Recent electroconvulsive therapy

- Patients who have been on BI 409306, encenicline or other investigational drug testing
effects on cognition in schizophrenia within the last 6 months prior to randomisation
or who have previously been on bitopertin

- Participation in a clinical trial with repeated Measurement and Treatment Research to
Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
assessments within the last 6 months

- Patients who required change in ongoing stable benzodiazepine or sleep medication
regimen within the last 4 weeks prior to randomisation

- Treatment with Clozapine within 6 months prior to randomisation

- Treatment with medical devices (e.g. Transcranial Magnetic Stimulation (TMS),
neurofeedback) for any psychiatric condition within the last 3 months prior to
randomisation

- Patients taking strong or moderate Cytochrome P450 (CYPA4) inhibitors or inducers
within the last 30 days prior to randomization

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

- 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) prior to randomisation

- Known history of Human Immunodeficiency Virus (HIV) infection and/or a positive result
for ongoing Hepatitis B or C infection on the Visit 1 central lab report

- Hemoglobin less than 120 g/L (12g/dL) in men or 115 g/L (11.5 g/dL) in women

- History of hemoglobinopathy such as thalassemia major or sickle-cell anemia

- Women who are pregnant, nursing, or who plan to become pregnant while in the trial or
men who are able to father a child, unwilling to be abstinent or use adequate
contraception for the duration of the study participation and for at least 28 days
after treatment has ended

- Significant history of drug abuse disorder (including alcohol) within the last 6
months prior to informed consent or a positive urine drug screen at screening (except
for Benzodiazepines taken according to prescription and as an ongoing, stable regimen)

- Further exclusion criteria apply