A study to test long-term safety of Iclepertin in people with schizophrenia who took part in a previous CONNEX study

Other illness

• Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial
• Patients diagnosed with moderate or severe substance use disorder

Lab values

• Haemoglobin- Hb drop below 100g/L (10g/dL) OR Hb decrease of 25% or more from baseline and is below lower limit of normal in parent trial (alert 3 from last measure Hb in parental trial)

Other

• Any suicidal behavior and/ or suicidal ideation of type 5 based on the C-SSRS in parent trial and up to and including Visit 1 of this study.
• Patients who have been diagnosed with hemoglobinopathies during the parent trial.
• Further exclusion criteria apply.

• Clinically stable outpatients who have been diagnosed with schizophrenia (as per Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5))
• "Patients, who completed 26 weeks of treatment in the parent trial, must enter the extension trial: - Within 2 weeks the end of treatment visit in 1346-0011, 1346-0013 (i.e. Follow Up 1 timepoint including the applicable time windows). - At the end of safety follow up in 1346-0012 (within 7 days of visit Follow Up 6)."
• Have a study partner, defined as any person capable of understanding trial related procedures, with a minimum of 8th grade level of education, who knows the patient well, has been capable of interacting with the patient on a regular basis. Preferably be the same person throughout the study.
• Further inclusion criteria apply.