This Study Tests Whether BI 425809 Together With Brain Training Using a Computer Improves Mental Functioning in Patients With Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT03859973

Run by

Boehringer Ingelheim

People needed

200

Starts

2019-04-15

Expected to finish

2022-11-04

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Atria Clinical Research — Little Rock, Arkansas, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• Encino Hospital Medical Center — Encino, California, United States
• Collaborative Neuroscience Network, LLC (CNS) — Garden Grove, California, United States
• Synergy San Diego — Lemon Grove, California, United States
• Catalina Research Institute, LLC — Montclair, California, United States
• Pacific Research Partners, LLC — Oakland, California, United States
• NRC Research Institute — Orange, California, United States
• CNRI - Los Angeles — Pico Rivera, California, United States
• CNRI-San Diego, LLC — San Diego, California, United States
• Collaborative Neuroscience Network, LLC (CNS) — Torrance, California, United States
• Meridien Research — Maitland, Florida, United States
• Premier Clinical Research Institute — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Apalachee Center — Tallahassee, Florida, United States
• Jerome Golden Center for Behavioral Health — West Palm Beach, Florida, United States
• Synexus — Atlanta, Georgia, United States
• Uptown Research Institute — Chicago, Illinois, United States
• Lake Charles Clinical Trials LLC — Lake Charles, Louisiana, United States
• Cherry Health — Grand Rapids, Michigan, United States
• Center for Behavioral Medicine — Kansas City, Missouri, United States
• Synexus Clinical Research US, Inc. — New York, New York, United States
• UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center — Raleigh, North Carolina, United States
• Midwest Clinical Research — Dayton, Ohio, United States
• FutureSearch Trials of Dallas, LP — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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