Safety and Tolerability of BI 409306 in Patients With Schizophrenia

Inclusion criteria

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

• Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks.
• Maintained on current antipsychotic medications and current dose for at least 8 weeks.
• 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).
• Have no more than a moderate severity rating on positive formal thought disorder (e.g. BPRS Conceptual Disorganization item score < or =4).
• Have no more than a moderate severity rating on negative symptoms (Positive and Negative Syndrome Scale negative syndrome total score <15).
• 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).
• Male or female patients age > or = 18 and < or =55 years.
• Patients must exhibit reliability and physiologic capability to comply with all protocol procedures.
• 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

• Patient treated with more than one antipsychotic or not stabilized on antipsychotic treatment, or having had electroconvulsive therapy within the last 30 days
• Patient's cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator.
• Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
• 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).
• 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.
• Any evidence of a clinically relevant concomitant disease.
• History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological or hormonal disorders.
• Female patients that are of child-bearing potential or currently breastfeeding.
• Known history, or new diagnosis per screening labs, of HIV infection.
• 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
• History of malignancy within the last 5 years, except for basal cell carcinoma.
• Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day during the study period.
• Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this clinical trial.
• 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.
• Participation in another trial with an investigational drug or procedure within 30 days prior to screening or previous participation in any BI 409306 study.