This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: BI 425809; Placebo
Intervention description: Tablet; Tablet
Intervention MeSH terms: BI 425809
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This is a study in adults with schizophrenia. The study tests whether a medicine called BI
      425809 together with brain training improves mental abilities.

      Participants take study medication once a day for 12 weeks. At the start of the study, the
      participants are put into 2 groups. It is decided by chance who gets into which group. One
      group gets BI 425809 tablets every day. The other group gets placebo tablets every day.
      Placebo tablets look like the BI 425809 tablets, but contain no medicine. During the study,
      all participants do brain training using a computer.

      The doctors regularly test mental abilities of the participants. The results of the mental
      ability tests are compared between the groups. The doctors also check the general health of
      the patients.
    

Eligibility criteria:

        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; also, current antipsychotic
             medications and concomitant anticholinergics, antiepileptics, lithium and allowed
             antidepressants must meet the criteria below:

               -  Patients must take 1 and may take up to 2 antipsychotics (typical and/or
                  atypical), except for clozapine

               -  Patients must be stable on current antipsychotics, 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 o 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. A list of contraception methods meeting these criteria is provided in
             Section 4.2.2.3. 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 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)3.

          -  Patients must be able to comply with all protocol procedures, 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.

        Exclusion Criteria:

          -  Patients who have a categorical diagnosis of another current major psychiatric
             disorder on the Mini-International Neuropsychiatric Interview (M.I.N.I.).

          -  Diseases of the central nervous system (CNS) that may impact the assessment of the
             cognitive tests as per investigator's opinion. A movement disorder due to
             antipsychotic treatment not currently controlled with anti- EPS treatment or another
             movement disorder (e.g. Parkinson´s disease).

          -  Patients with a history of participating in any formal cognitive remediation program
             for 10 or more training sessions.

          -  Patients who were treated with any of the following medications within the last 6
             months prior to randomization:

               -  Bitopertin, BI 409306, encenicline or other investigational drug testing effects
                  on cognition in schizophrenia

               -  Clozapine (atypical antipsychotic medication)

               -  Sarcosine, cycloserine, serine and glycine

               -  Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)

               -  Tricyclic antidepressants

          -  Patients receiving any other investigational drug (other than a potential cognitive
             enhancing drug) within 30 days or 6 half-lives (whichever is longer) prior to
             randomization. For investigational LAI antipsychotics, the last injection must be at
             least 3 months or two administration cycles (i.e. 6 months if administration is every
             3 months) prior to randomization, whichever is longer.

          -  Patients who have participated in a clinical trial with repeated assessments (i.e. a
             single assessment is not exclusionary) with the MATRICS Consensus Cognitive Battery
             (MCCB) within the last 6 months prior to randomization.

          -  Patients who required a change in ongoing benzodiazepine or sleep medication dose or
             regimen within the last 30 days prior to randomization.

          -  Patients with known active infection with SARS-CoV-2 within the last 30 days prior to
             randomization.

          -  Other exclusion criteria apply