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

Phase 1

• Conditions: Schizophrenia; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2024-511560-93-00
• Lead Sponsor: Boehringer Ingelheim International GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1479

Inclusion Criteria

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.

Exclusion Criteria

Participant who developed DSM-5 diagnosis other than Schizophrenia or any condition that would prevent the patient from participating in the extension trial, 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 diagnosed with moderate or severe substance use disorder, 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), Patients who have been diagnosed with hemoglobinopathies during the parent trial., Further exclusion criteria apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified