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SchizophreniaPhase 2NCT02832037

Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia

A Phase 2 study testing BI 425809 dose 1, BI 425809 dose 2 and BI 425809 dose 3 in people with Schizophrenia, run by Boehringer Ingelheim at 81 sites in 11 countries.

Completed

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

Official record
Search all trials

Trial summary

The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment. 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 dose 1, BI 425809 dose 2 and BI 425809 dose 3
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
509 participants
Where
81 sitesin 11 countries
Study dates
25 Jul 2016to 29 Jan 2020
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

  • Men or women who are 18-50 years (inclusive) of age at time of consent
  • Established schizophrenia with the following clinical features:
  • Outpatient, with no hospitalization for worsening of schizophrenia within 3 months prior to randomisation
  • Medically stable over the prior 4 weeks and psychiatrically stable without symptom exacerbation within 3 months prior to randomisation
  • patients who have no more than a moderate severe rating on the Positive and Negative Symptom Scale (PANSS) positive items P1, P3-P7 and no more than a moderate rating on the PANSS positive item P2
  • Current antipsychotic and concomitant psychotropic medications as assessed at Visit 1 must meet the criteria below:
Show all 13Show fewer
  • patients may have up to 2 antipsychotics (typical and/or atypical)
  • patients must be maintained on current typical and/or atypical antipsychotics other than Clozapine and on current dose for at least 4 weeks prior to randomisation and/or maintained on current long acting injectable antipsychotics and current dose for at least 3 months prior to randomization
  • patients must be maintained on current concomitant psychotropic medications, anticholinergics, antiepileptics and/or lithium for at least 3 months prior to randomisation and on current dose for at least 4 weeks prior to randomisation
  • Women of child-bearing potential must be ready and able to use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly.
  • Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures, in the investigator´s opinion
  • Patients must have an identified informant who will be consistent throughout the study.
  • Further inclusion criteria apply

Who cannot join

  • Patients who have a categorical diagnosis of another current major psychiatric disorder
  • Diseases of the central nervous system that may impact cognitive test performance
  • Movement disorder not currently controlled
  • Patients receiving another investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or recent participation in another trial with any cognitive enhancing therapy
  • Recent participation in formal cognitive remediation program
  • Recent electroconvulsive therapy
Show all 20Show fewer
  • Patients who have been on BI 409306, encenicline or other investigational drug testing effects on cognition in schizophrenia within the last 6 months prior to randomisation or who have previously been on bitopertin
  • Participation in a clinical trial with repeated Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) assessments within the last 6 months
  • Patients who required change in ongoing stable benzodiazepine or sleep medication regimen within the last 4 weeks prior to randomisation
  • Treatment with Clozapine within 6 months prior to randomisation
  • Treatment with medical devices (e.g. Transcranial Magnetic Stimulation (TMS), neurofeedback) for any psychiatric condition within the last 3 months prior to randomisation
  • Patients taking strong or moderate Cytochrome P450 (CYPA4) inhibitors or inducers within the last 30 days prior to randomization
  • Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to randomisation
  • Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent) prior to randomisation
  • Known history of Human Immunodeficiency Virus (HIV) infection and/or a positive result for ongoing Hepatitis B or C infection on the Visit 1 central lab report
  • Hemoglobin less than 120 g/L (12g/dL) in men or 115 g/L (11.5 g/dL) in women
  • History of hemoglobinopathy such as thalassemia major or sickle-cell anemia
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial or men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of the study participation and for at least 28 days after treatment has ended
  • Significant history of drug abuse disorder (including alcohol) within the last 6 months prior to informed consent or a positive urine drug screen at screening (except for Benzodiazepines taken according to prescription and as an ongoing, stable regimen)
  • Further exclusion criteria apply

Trial locations and contacts

81 sites in 11 countries.

81 sites in 11 countries

United States21 sites

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

  • Synexus

    Atlanta, Georgia, 30328

  • Atlanta Center

    Atlanta, Georgia, 30331

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • University at Buffalo, The State University of New York

    Buffalo, New York, 14215

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • Uptown Research Institute

    Chicago, Illinois, 60640

  • Midwest Clinical Research

    Dayton, Ohio, 45417

  • InSite Clinical Research

    DeSoto, Texas, 75115

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845

  • Lake Charles Clinical Trials LLC

    Lake Charles, Louisiana, 70629

  • Synergy San Diego

    Lemon Grove, California, 91945

  • Premier Clinical Research Institute

    Miami, Florida, 33122

  • NRC Research Institute

    Orange, California, 92868

  • Alliance for Wellness

    Panorama City, California, 91402

  • CNRI - Los Angeles

    Pico Rivera, California, 90660

  • North Carolina Psychiatric Research Center

    Raleigh, North Carolina, 27610

  • Finger Lakes Clinical Research

    Rochester, New York, 14618

  • Psychiatric and Behavioral Solutions, LLC

    Salt Lake City, Utah, 84105

  • CNRI-San Diego, LLC

    San Diego, California, 92102

  • Mid-America Clinical Research, LLC

    St Louis, Missouri, 63109

Other trials in United States

Japan14 sites

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

  • National Center for Global Health and Medicine Kohnodai Hospital

    Chiba, Ichikawa, 272-8516

  • Hospital of the University of Occupational and Environmental Health

    Fukuoka, Kitakyushu, 807-8556

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Kobe University Hospital

    Hyogo, Kobe, 650-0017

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793

  • Kishiro Mental Clinic

    Kanagawa, Kawasaki, 214-0014

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522

  • Kansai Medical University Medical Center

    Osaka, Moriguchi, 570-8507

  • Iwaki Clinic, Tokushima, Psychosomatic Medicine

    Tokushima, Anan, 774-0014

  • National Center Neurology and Psychiatry

    Tokyo, Kodaira, 187-8851

  • Showa University Karasuyama Hospital

    Tokyo, Setagaya, 157-8577

  • Tokyo Women's Medical University Hospital

    Tokyo, Shinjuku-ku, 162-8666

Other trials in Japan

Germany7 sites

  • Zentrum für klinische Forschung Dr. med. Irma Schöll & Kollegen

    Bad Homburg, 61348

  • Praxis Dr. Volker Schumann

    Berlin, 10245

  • Berufsausübungsgemeinschaft, Dr. sc. med. Alexander Schulze und Prof. Dr. med. Hagen Kunte

    Berlin, 13156

  • Praxis Dr. Hahn, Berlin

    Berlin, 13187

  • PANAKEIA Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275

  • Zentralinstitut für seelische Gesundheit

    Mannheim, 68159

  • Neurologie und Psychiatrie / Psychotherapie

    Westerstede, 26655

Other trials in Germany

Poland7 sites

  • Wlokiennicza Med,Spec.Med.Prac,MD Tomasz Markowski,Bialystok

    Bialystok, 15 464

  • Podlassian Center of Psychogeriatry, Bialystok

    Bialystok, 15-756

  • Osrodek Badan Klinicznych CLINSANTE S.C.

    Bydgoszcz, 85794

  • Non-public Health Care Psychiatric Institution MENTIS,Leszno

    Leszno, 64100

  • EUROMEDIS Sp. z o.o., Szczecin

    Szczecin, 70-111

  • Clin.Research Centre Clinsante SC Ewa Galczak-Nowak,Torun

    Torun, 87-100

  • Therapy Centre DIALOG Sp.z o.o. S.j.

    Warsaw, 02-791

Other trials in Poland

South Korea7 sites

  • Chonnam National University Hospital

    Gwangju, 61453

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • National Center for Mental Health

    Seoul, 04933

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Spain6 sites

  • Hospital del Mar

    Barcelona, 08003

  • Centro de Salud Mental de Fuencarral

    Madrid, 28029

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital Puerta de Hierro

    Majadahonda (Madrid), 28222

  • Centro de Salud de San Juan

    Salamanca, 37005

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

Other trials in Spain

Canada5 sites

  • Chatham-Kent Clinical Trials Research Centre

    Chatham, Ontario, N7L 1C1

  • IUSMM Institut Universitaire en Sante Mentale de Montreal

    Montreal, Quebec, H1N 3M5

  • Dr. Alexander McIntyre Inc.

    Penticton, British Columbia, V2A 4M4

  • Centre for Addiction and Mental Health (CAMH)

    Toronto, Ontario, M5T 1R8

  • The Medical Arts Health Research Group

    Vancouver, British Columbia, V7T 1C5

Other trials in Canada

United Kingdom5 sites

  • Bushey Fields Hospital

    Dudley, DY1 2LZ

  • Royal Edinburgh Hospital

    Edinburgh, EH10 5HF

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • King's College Hospital

    London, SE5 8AF

  • Royal Cornwall Hospital

    Truro, TR1 3HD

Other trials in United Kingdom

Taiwan4 sites

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10016

  • Taipei City Hospital

    Taipei, 110

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

Italy3 sites

  • ASST degli Spedali Civili di Brescia

    Concesio (BS), 25062

  • Asst Santi Paolo E Carlo

    Milan, 20142

  • Azienda Sanitaria Ospedale S. Luigi Gonzaga

    Orbassano (TO), 10043

Other trials in Italy

Austria2 sites

  • Medical University of Innsbruck

    Innsbruck, 6020

  • AKH - Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase II Randomised, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 425809 Once Daily Over 12 Week Treatment Period in Patients With Schizophrenia

The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

Conditions
Schizophrenia
Being tested
BI 425809 dose 1, BI 425809 dose 2, BI 425809 dose 3, BI 425809 dose 4, 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 425809 dose 1Drug

  • BI 425809 dose 2Drug

  • BI 425809 dose 3Drug

  • BI 425809 dose 4Drug

  • PlaceboDrug

Study groups in NCT02832037
Study groupRoleWhat they receive
BI 425809 dose 1ExperimentalNot described
Receives: Drug: BI 425809 dose 1; Drug: Placebo
BI 425809 dose 2ExperimentalNot described
Receives: Drug: BI 425809 dose 2; Drug: Placebo
BI 425809 dose 3ExperimentalNot described
Receives: Drug: BI 425809 dose 3; Drug: Placebo
BI 425809 dose 4ExperimentalNot described
Receives: Drug: BI 425809 dose 4; Drug: Placebo
PlaceboPlacebo 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 Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment

    MCCB overall composite T-score was derived from scores of 7 cognitive domains (Speed of Processing, Verbal Learning, Working Memory, Reasoning and Problem Solving, Visual Learning, Social Cognition, Attention) obtained from a total of 10 tests (Trail Making, Brief Assessment of Cognition in Schizophrenia, Hopkins Verbal Learning, Wechsler Memory Scale, Letter-Number Span, Neuropsychological Assessment Battery, Brief Visuospatial Memory, Category Fluency, Mayer-Salovey-Caruso Emotional Intelligence, Continuous Performance) and ranges typically between -20 and +99, a larger T-score indicates better cognition.

    Change from baseline in MCCB overall composite T-score after 12 weeks of treatment was modeled using a MMRM with fixed, categorical factors of treatment at each visit, and continuous factors of baseline at each visit, using visit (week 6 and week 12 of treatment) as repeated measures, subject as random effect, adjusted mean (standard error) after 12 weeks of treatment is reported.

    Measured: Baseline, after 6 and 12 weeks of treatment

Secondary outcomes (2)

  1. Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 12 Weeks of Treatment

    SCoRS total score was derived as the sum of non-missing responses from 20 interview-based items rated by an interviewer on a 4-point scale. A response of "not available" to an item was treated as missing. If six or more of the 20 items were missing for a participant at a visit, then the corresponding SCoRS total score was missing for that participant at the visit. If five or less of the 20 items were missing for a participant at a visit, then the item(s) with missing value(s) were imputed first with the average of the non-missing item values, then the SCoRS total score for the participant at the visit was derived as the sum of non-missing item values and the imputed item values. 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.

    Analysis of covariance model was fitted to calculate adjusted mean and standard error, model details in the Statistical Analysis section.

    Measured: Baseline and after 12 weeks of treatment

  2. Percentage of Participants With Any Adverse Event

    Percentage of participants with any Adverse Event.

    Measured: On-treatment period, that is, from first intake of any trial drug until the last intake of any trial drug (planned: 84 days) + residual effect period (11 days), up to 103 days

Timeline

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

  1. First posted13 Jul 2016 (estimated)
  2. Study start25 Jul 2016
  3. Primary completion27 Dec 2019
  4. Study completion29 Jan 2020

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
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02832037
Sponsor's protocol ID
1346.9
Other IDs
2016-000285-28, 2016
Status last verified
Feb 2021
First submitted
7 Jul 2016
Last updated
24 Feb 2021

Publications

  • Schultheis C, Rosenbrock H, Mack SR, Vinisko R, Schuelert N, Plano A, Sussmuth SD. Quantitative electroencephalography parameters as neurophysiological biomarkers of schizophrenia-related deficits: A Phase II substudy of patients treated with iclepertin (BI 425809). Transl Psychiatry. 2022 Aug 11;12(1):329. doi: 10.1038/s41398-022-02096-5.

    PubMed 35953474

  • Fleischhacker WW, Podhorna J, Groschl M, Hake S, Zhao Y, Huang S, Keefe RSE, Desch M, Brenner R, Walling DP, Mantero-Atienza E, Nakagome K, Pollentier S. Efficacy and safety of the novel glycine transporter inhibitor BI 425809 once daily in patients with schizophrenia: a double-blind, randomised, placebo-controlled phase 2 study. Lancet Psychiatry. 2021 Mar;8(3):191-201. doi: 10.1016/S2215-0366(20)30513-7.

    PubMed 33610228

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 425809 dose 1, BI 425809 dose 2 and BI 425809 dose 3 in people with Schizophrenia, run by Boehringer Ingelheim at 81 sites in 11 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 20 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 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Japan, Germany, Poland, South Korea and 6 more countries. 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 24 Feb 2021). 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 Cognitive Function as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Overall Composite T-score After 12 Weeks of Treatment (time frame: Baseline, after 6 and 12 weeks of treatment). 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 NCT02832037, 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 24 Feb 2021.

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