Summary:
The primary objective of this Phase II exploratory trial is to provide Proof of Concept (PoC) data to assess the effect on cognition of oral once daily administration of BI 425809 given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment and adjunctive Computerized Cognitive Training (CCT).
Inclusion Criteria:
- Signed and dated written informed consent in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
- Male or female patients who are 18-50 years (inclusive) of age at time of consent.
Established schizophrenia (as per DSM-5) with the following clinical features:
- Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomization
- Psychiatrically stable without symptom exacerbation within 3 months prior to randomization
- PANSS score ≤ 5 on positive items P1, P3-P7 and ≤ 4 on positive item P2 at Visit 1, and confirmed at Visit 2
Patients must be on stable antipsychotic treatment, and current antipsychotic and concomitant psychotropic medications must meet the criteria below:
- Patients may take up to 2 antipsychotics (typical and/or atypical), except for clozapine
- Patients must be stable on current antipsychotics and concomitant psychotropic medications (e.g. anticholinergics, antiepileptics, lithium and allowed antidepressants) for at least 3 months prior to randomization and be on current dose for at least 30 days prior to randomization ---Patients on Long-Acting Injectable (LAI) antipsychotics should be on the same medication and dose for at least 3 months prior to randomization
- Women of childbearing potential (WOCBP)2 must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial.
- Patients must demonstrate their ability to properly use the computerized cognitive training (CCT) device and program, as well as be compliant with CCT run-in (defined as completing at least 2 hours per week for two weeks, totalling 4 hours CCT, during the screening period).
- Patients must be able to comply with all protocol procedures including the at-home CCT exercises, in the investigator's opinion.
- Patients must have a study partner who will preferably be consistent throughout the study. It is recommended that the study partner should interact (in-person or telephone) with the subject at least 2 times a week.
Qualified Participants May Receive:
Monetary compensation and study-related care at no cost to the participant