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SchizophreniaPhase 2NCT03859973

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

A Phase 2 study testing BI 425809 in people with Schizophrenia, run by Boehringer Ingelheim at 50 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Schizophrenia
What is being tested?
BI 425809
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
50 sitesin 6 countries
Study dates
15 Apr 2019to 4 Nov 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

50 sites in 6 countries.

50 sites in 6 countries

United States28 sites

  • Synexus

    Atlanta, Georgia, 30328

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Uptown Research Institute

    Chicago, Illinois, 60640

  • FutureSearch Trials of Dallas, LP

    Dallas, Texas, 75231

  • Midwest Clinical Research

    Dayton, Ohio, 45417

  • Encino Hospital Medical Center

    Encino, California, 91436

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845

  • Cherry Health

    Grand Rapids, Michigan, 49503

  • Center for Behavioral Medicine

    Kansas City, Missouri, 64108

  • Lake Charles Clinical Trials LLC

    Lake Charles, Louisiana, 70629

  • Synergy San Diego

    Lemon Grove, California, 91945

  • Atria Clinical Research

    Little Rock, Arkansas, 72209

  • Meridien Research

    Maitland, Florida, 32751

  • Premier Clinical Research Institute

    Miami, Florida, 33122

  • University of Miami

    Miami, Florida, 33136

  • Catalina Research Institute, LLC

    Montclair, California, 91763

  • Synexus Clinical Research US, Inc.

    New York, New York, 10017

  • Pacific Research Partners, LLC

    Oakland, California, 94607

  • NRC Research Institute

    Orange, California, 92868

  • CNRI - Los Angeles

    Pico Rivera, California, 90660

  • UNC Center for Excellence in Community Mental Health, North Carolina Psychiatric Research Center

    Raleigh, North Carolina, 27608

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • Office of Dr. Aqeel Hashmi, MD, PA

    Richmond, Texas, 77407

  • Woodland Research Northwest

    Rogers, Arkansas, 72758

  • CNRI-San Diego, LLC

    San Diego, California, 92102

  • Apalachee Center

    Tallahassee, Florida, 32308

  • Collaborative Neuroscience Network, LLC (CNS)

    Torrance, California, 90502

  • Jerome Golden Center for Behavioral Health

    West Palm Beach, Florida, 33407

Other trials in United States

France8 sites

  • CTR Esquirol

    Caen, 14033

  • HOP Dijon-Bourgogne

    Dijon, 21079

  • CAB Médical Psyché

    Douai, 59500

  • HOP la Colombière

    Montpellier, 34295

  • HOP Saint-Jacques

    Nantes, 44093

  • HOP Pasteur

    Nice, 06000

  • GHU Paris Psychiatrie et Neurosciences

    Paris, 75674

  • HOP Nord

    Saint-Priest-en-Jarez, 42270

Other trials in France

United Kingdom5 sites

  • The Fritchie Centre

    Cheltenham, GL53 9DZ

  • Royal Edinburgh Hospital

    Edinburgh, EH10 5HF

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Maudsley Hospital

    London, SE5 8AZ

  • Warneford Hospital

    Oxford, OX3 7JX

Other trials in United Kingdom

Australia4 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Monash Alfred Psychiatry Research Centre

    Melbourne, Victoria, 3004

Other trials in Australia

Canada4 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • IUSMM Institut Universitaire en Sante Mentale de Montreal

    Montreal, Quebec, H1N 3M5

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M6J 1H4

  • BC Mental Health and Addictions Research Institute (University of British Columbia)

    Vancouver, British Columbia, V5Z 4H4

Other trials in Canada

New Zealand1 site

  • North Shore Hospital, Takapuna

    Takpuna Auckland, 0622

Other trials in New Zealand

About this study

Official title: A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily With Adjunctive Computerized Cognitive Training Over 12 Week Treatment Period in Patients With Schizophrenia

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.

Conditions
Schizophrenia
Being tested
BI 425809, Placebo
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 425809Drug

    Also called iclepertin

    Tablet

  • PlaceboDrug

    Tablet

Study groups in NCT03859973
Study groupRoleWhat they receive
BI 425809 10 mg + Computerized Cognitive TrainingExperimentalNot described
Receives: Drug: BI 425809
Placebo + Computerized Cognitive TrainingPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Neurocognitive Function as Measured by the Neurocognitive Composite Score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment

    MCCB neurocognitive composite T-score assesses 6 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving. MCCB neurocognitive T-scores in the general population have a mean of 50 and standard deviation of 10. A higher T-score indicates better cognition. Change from baseline in MCCB neurocognitive composite T-score at Week 12 was modelled based on a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.

    Measured: At screening (28 days prior to first drug drug administration), at baseline and at Weeks 6 and 12 after first drug administration.

Secondary outcomes (4)

  1. Change From Baseline in Cognitive Function as Measured by the Overall MCCB Composite T Score (Including Social Cognition) After 12 Weeks of Treatment

    MCCB cognitive score comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. MCCB cognitive T-scores in the general population have a mean of 50 and standard deviation of 10. A higher T-score indicates better cognition. Change from baseline in MCCB overall composite T-score was modelled using a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (screening, baseline, week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group, and continuous covariate of change from screening to baseline value. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.

    Measured: At screening (28 days prior to first drug drug administration), at baseline and at Weeks 6 and 12 after first drug administration.

  2. Change From Baseline in the Effect of Cognitive Deficit on Day-to-day Functioning as Measured by SCoRS Total Score After 12 Weeks of Treatment

    Schizophrenia Cognition Rating Scale (SCoRS) is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. SCoRS total score is between 20 and 80 where higher score values represent greater degree of impairment in day-to-day functions due to cognitive deficits. The composite score was the average of non-missing responses. If five or more of the 20 items were missing, the composite score was missing for that participant at the visit.

    Change from baseline in SCoRS total score after 12 weeks of treatment was modelled using an Analysis of Covariance (ANCOVA) which included the following fixed effects: categorical factor of planned treatment, continuous covariate of baseline value, categorical factor of age group.

    Measured: At baseline and at 12 weeks after first drug administration.

  3. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score After 12 Weeks of Treatment

    PANSS was used to evaluate broad psychopathology associated with schizophrenia disease state. The PANSS has 30 items. Each is rated from 1 to 7 points. The total factor score is the summation of the actual points for each item, leading the total score ranging from 30 to 210; a higher score indicates a worse disease condition.

    Change from baseline in PANNS total score after 12 weeks of treatment was modelled based on a restricted maximum likelihood (REML) based approach using a mixed model with repeated measurements (MMRM) which included the following fixed effects: categorical factor of planned treatment, visit (baseline, Week 6 and Week 12), planned treatment by visit interaction, continuous covariate of baseline value, baseline by visit interaction, categorical factor of age group. The Least Squares Mean (95 % Confidence Interval) at Week 12 is reported.

    Measured: At baseline and at Weeks 6 and 12 after first drug administration.

  4. Percentage of Patients With Any Adverse Event (AE) and With Serious Adverse Events (SAEs)

    Percentage of patients with any Adverse Event (AE) and with serious adverse events (SAEs) is reported.

    Percentages were rounded to one decimal place.

    Measured: From first dose of study drug administration until four weeks after the last dose of study drug administration, up to 16 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start15 Apr 2019
  3. Primary completion30 Sep 2022
  4. Study completion4 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859973
Sponsor's protocol ID
1346-0038
Other IDs
2018-002740-82, 2018
Status last verified
Oct 2023
First submitted
25 Feb 2019
Last updated
18 Nov 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.

Publications

  • Harvey PD, McDonald S, Fu E, Reuteman-Fowler C. Efficacy and safety of iclepertin (BI 425809) with adjunctive computerized cognitive training in patients with schizophrenia. Schizophr Res Cogn. 2024 Dec 14;40:100340. doi: 10.1016/j.scog.2024.100340. eCollection 2025 Jun.

    PubMed 39759424

  • Harvey PD, Bowie CR, McDonald S, Podhorna J. Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial. Clin Drug Investig. 2020 Apr;40(4):377-385. doi: 10.1007/s40261-020-00893-8.

    PubMed 32036587

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 425809 in people with Schizophrenia, run by Boehringer Ingelheim at 50 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, France, United Kingdom, Australia, Canada and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Neurocognitive Function as Measured by the Neurocognitive Composite Score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment (time frame: At screening (28 days prior to first drug drug administration), at baseline and at Weeks 6 and 12 after first drug administration.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859973, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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