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SchizophreniaPhase 2NCT03351244

This Study Tests Whether BI 409306 Prevents Patients With Schizophrenia From Becoming Worse. This Study Looks at How Well Patients Tolerate BI 409306 and How Effective it is Over 6 Months

A Phase 2 study testing BI 409306 in people with Schizophrenia, run by Boehringer Ingelheim at 59 sites in 7 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Schizophrenia
What is being tested?
BI 409306
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
264 participants
Where
59 sitesin 7 countries
Study dates
7 Dec 2017to 31 Mar 2021
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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10) diagnosis of schizophrenia >= one year prior to randomisation.
  • Outpatients in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with treating clinician.
  • Patients currently taking a stable dose of antipsychotic medication(s) for at least 12 weeks prior to randomisation.
  • Detectable level of current antipsychotic medication(s) in plasma from blood drawn at Visit 1 (unless no assay is available for the antipsychotic(s) currently prescribed).
  • Patients who have experienced at least 2 relapses within the past 5 years or at least 1 relapse if they were diagnosed less than 3 years ago. Relapse is defined as the patient having any of the following using the above number of relapses and time frames:
  • Hospitalization for psychosis (involuntary or voluntary admission), intensive outpatient therapy or use of home treatment as an alternative to hospitalization (verified via medical record).
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  • Emergency Department visit for worsening schizophrenia symptoms (verified via medical record).
  • Deliberate self-injury and/or violent behaviour resulting in significant injury to another person or property (verified by police record or treating mental health provider written record or documented phone conversation).
  • Change in the patient's antipsychotic medication or increase in antipsychotic medication dosage due to worsening of schizophrenia symptoms (verified by pharmacy records or treating mental health provider written record or documented phone conversation).
  • Clinical Global Impressions-Severity (CGI-S) score ≤4 at Visit 1 and 2.
  • Positive and Negative Syndrome Scale (PANSS) total score <80 and a score of ≤ 4 on individual PANSS items conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content at Visit 1.
  • Of full age (according to local legislation, usually ≥ 18 years) and ≤ 55 years at the time of informed consent.
  • Patients must have an identified informant who will be consistent throughout the study.
  • Patients who report living at the same address for the 3 months prior to randomisation.
  • Male or female patients.
  • -- Female patients of childbearing potential must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
  • Signed and dated written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. If the patient has a legal representative, then this legal representative must give written informed consent as well.

Who cannot join

  • Patients treated with more than two antipsychotic medications (including more than two dosage forms).
  • Patients who are currently being treated with clozapine, or who have been treated with clozapine in the past 5 years.
  • Patients with a categorical diagnosis of another current major psychiatric disorder per the Mini-international neuropsychiatric Interview (M.I.N.I.).
  • Homicidal behaviour (in the investigator's judgement) in the past 2 years.
  • Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
  • Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
Show all 20Show fewer
  • In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient's safety while participating in the clinical trial.
  • Other known neurological diseases (including but not limited to any kind of seizures or stroke).
  • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
  • Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
  • Significant history of drug or alcohol dependence or abuse (Substance Use Disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) or ICD-10) within the last six months prior to informed consent. (Not including caffeine or nicotine).
  • Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  • Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be strong or moderate inhibitors of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the Investigator Site File (ISF)).
  • Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF)
  • Patients with a history of moderate to severe hepatic impairment (Child-Pugh B / C).
  • Patients with a history of moderate to severe renal impairment (Stage 3 - 5).
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • In the judgment of the investigator, inability of the patient to comply with the clinical trial procedures.
  • Currently enrolled in another investigational device or drug study, or less than 6 months from Visit 1 since ending another investigational device or drug study(s), or participation in > 2 investigational drug clinical trials in the past 2 years.
  • Previous randomisation in any BI 409306 study.

Trial locations and contacts

59 sites in 7 countries.

59 sites in 7 countries

United States32 sites

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

  • Atlanta Center

    Atlanta, Georgia, 30331

  • Community Clinical Research, Inc.

    Austin, Texas, 78754

  • Hassman Research Institute

    Berlin, New Jersey, 08009

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516

  • Alam Medical Research, Inc.

    Chicago, Illinois, 60612

  • ATP Clinical Research, Inc.

    Costa Mesa, California, 92626

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Collaborative Neuroscience Network, LLC (CNS)

    Garden Grove, California, 92845

  • Behavioral Research Specialists, LLC

    Glendale, California, 91206

  • MD Clinical

    Hallandale, Florida, 33009

  • Reliable Clinical Research

    Hialeah, Florida, 33012

  • University Hills Clinical Research

    Irving, Texas, 75062

  • Lake Charles Clinical Trials LLC

    Lake Charles, Louisiana, 70629

  • Altea Research Institute

    Las Vegas, Nevada, 89102

  • Synergy East

    Lemon Grove, California, 91945

  • University of California Los Angeles

    Los Angeles, California, 90095

  • Meridien Research

    Maitland, Florida, 32751

  • Clinical Trials of America, LLC

    Monroe, Louisiana, 71201

  • New York State Psychiatric Institute

    New York, New York, 10032

  • Manhattan Behavioral Medicine PLLC

    New York, New York, 10036

  • Behavioral Clinical Research, Inc.

    North Miami, Florida, 33161

  • Excell Research Inc.

    Oceanside, California, 92056

  • Orange County Neuropsychiatric Research Center LLC

    Orange, California, 92868

  • Meridien Research

    Orlando, Florida, 32810

  • Alea Research

    Phoenix, Arizona, 85012

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080

  • @Health Texas

    Richmond, Texas, 77407

  • St. Charles Psychiatric Associates & Midwest Research Group

    Saint Charles, Missouri, 63304

  • Arch Clinical Trials

    St Louis, Missouri, 63125

  • PsychCare Consultants Research

    St Louis, Missouri, 63128

  • Collaborative Neuroscience Network, LLC (CNS)

    Torrance, California, 90502

Other trials in United States

Japan10 sites

  • Okehazama Hospital Fujita Kokoro Care Center

    Aichi, Toyoake, 470-1168

  • Fujita Health University Hospital

    Aichi, Toyoake, 470-1192

  • National Center for Global Health and Medicine Kohnodai Hospital

    Chiba, Ichikawa, 272-8516

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Kuramitsu Hospital

    Fukuoka, Fukuoka, 819-0037

  • Soushu Hospital

    Kanagawa, Atsugi, 243-0201

  • Kishiro Mental Clinic

    Kanagawa, Kawasaki, 214-0014

  • Nara Medical University Hospital

    Nara, Kashihara, 634-8522

  • National Hospital Organization Hizen Psychiatric Medical Center

    Saga, Kanzaki-gun, 842-0192

  • National Center Neurology and Psychiatry

    Tokyo, Kodaira, 187-8851

Other trials in Japan

Canada6 sites

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

  • 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, M6J 1H4

  • The Medical Arts Health Research Group

    Vancouver, British Columbia, V7T 1C5

Other trials in Canada

France5 sites

  • HOP la Colombière

    Montpellier, 34295

  • GHU Paris Psychiatrie et Neurosciences

    Paris, 75674

  • HOP Guillaume Régnier

    Rennes, 35703

  • HOP Nord

    Saint-Priest-en-Jarez, 42270

  • HOP Sainte Musse

    Toulon, 83100

Other trials in France

South Korea3 sites

  • Chonnam National University Hospital

    Gwangju, 61453

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

Taiwan2 sites

  • NCKUH

    Tainan, 704

  • Taoyuan Psychiatric Center

    Taoyuan, 33058

Other trials in Taiwan

Spain1 site

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

Other trials in Spain

About this study

Official title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 28-week Treatment Period as Adjunctive Therapy to Antipsychotic Treatment for the Prevention of Relapse in Patients With Schizophrenia.

The objective of the study is to investigate the efficacy, safety and tolerability of BI 409306 once daily compared with placebo given for 28 weeks in patients with schizophrenia on antipsychotic treatment. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

Conditions
Schizophrenia
Being tested
BI 409306, 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 409306Drug

    28 week treatment period

  • PlaceboDrug

    28 week treatment period

Study groups in NCT03351244
Study groupRoleWhat they receive
BI 409306 50 mgExperimental1 film-coated tablet of 50 milligrams (mg) of BI 409306 plus 1 tablet of 25 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.
Receives: Drug: BI 409306
BI 409306 25 mgExperimental1 film-coated tablet of 25 milligrams (mg) of BI 409306 plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.
Receives: Drug: BI 409306
PlaceboPlacebo comparator1 film-coated tablet of 25 milligrams (mg) of matching Placebo plus 1 tablet of 50 mg matching placebo were administered orally once daily for a treatment period of 28 weeks, followed by a withdrawal/taper period of 7 days, followed by a follow-up period of 3 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Incidence Rate of First Relapse After 28 Weeks of Treatment

    The incidence rate of first relapse after 28 weeks of treatment is reported. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

    Measured: 28 weeks

Secondary outcomes (6)

  1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Symptoms Score After 28 Weeks of Treatment

    Positive and Negative Syndrome Scale (PANSS): assesses the severity of psychotic symptoms and progression of disease.

    The PANSS positive symptoms score is the sum of scores from 7 Items where each item has a minimum score 1 (better outcome) and maximum score 7 (worse outcome). The PANSS positive symptoms score ranges from 7 (less severe the disease) to 49 (more severe the disease).

    Measured: At baseline and at Week 28.

  2. Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 28 Weeks of Treatment

    Clinical Global Impressions-Severity (CGI-S): One-item evaluation completed by the clinician to measure the severity of psychopathology.

    The CGI-S score ranges from 1 (normal) through to 7 (most severely ill). The higher the score, the worse the psychopathology.

    Measured: At baseline and at Week 28

  3. Patient Global Impressions-Improvement (PGI-I) Scale Score After 28 Weeks of Treatment

    Patient Global Impressions-Improvement (PGI-I): One-item evaluation completed by the patient to assess their overall evaluation of his/her status compared to how they felt at randomisation.

    The PGI-I score ranges from 1 (Very much better) through to 7 (Very much worse). The higher the score, the worse the improvement.

    Measured: At Week 28

  4. Incidence Rate of Suicidal Ideation and Behaviour (Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)) After 28 Weeks of Treatment

    Columbia Suicide Severity Rating Scale (C-SSRS): suicide risk assessment. At a minimum, the interview consists of 2 screening questions related to suicidal ideation and 4 related to suicidal behavior, and may be expanded to up to 17 items in case of positive responses. Free text entries are allowed.

    Suicidal behavior is collected in nominal scale as presence/absence of actual attempts, non-suicidal self-injurious behavior, interrupted attempts, aborted attempts, preparatory acts or behavior, and any suicidal behavior.

    Suicidal ideation is rated on a 6-point scale from 0 (No ideation present) to 5 (Active ideation with plan and intent). A score of 4 or 5 on this scale indicates serious suicidal ideation.

    For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

    Measured: 28 weeks

  5. Change From Baseline in Personal and Social Performance Scale (PSP) Score After 28 Weeks of Treatment

    Personal and Social Performance scale (PSP): The PSP is a 100-point, single item, clinician rated scale to assess 4 domains of social functioning (Four domains over the past month: (1) socially useful activities, (2) personal and social relationships, (3) self-care and (4) disturbing and aggressive behaviors.) in patients with schizophrenia. The PSP score is a single score ranging from 1 to 100. Higher scores represent better personal and social functioning.

    Measured: At baseline and at Week 28

  6. Incidence Rate of New Prescription or Increase in Dose of an Ongoing Antipsychotic Medication

    The incidence rate of new prescription or increase in dose of an ongoing antipsychotic medication is reported. For each treatment group, the incidence rate was calculated as the number of events / sum of the observational time (patient year) over all participants in this treatment group.

    Measured: 28 weeks

Timeline

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

  1. First posted22 Nov 2017
  2. Study start7 Dec 2017
  3. Primary completion10 Mar 2021
  4. Study completion31 Mar 2021

Why it stopped: disruption due to COVID-19

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
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03351244
Sponsor's protocol ID
1289-0049
Other IDs
2017-002369-23, 2017
Status last verified
May 2025
First submitted
20 Nov 2017
Last updated
14 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the 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". Furthermore, researchers can 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.

Publications

  • Zhu Z, Roy D, Feng S, Vogler B. AI-based medication adherence prediction in patients with schizophrenia and attenuated psychotic disorders. Schizophr Res. 2025 Jan;275:42-51. doi: 10.1016/j.schres.2024.11.006. Epub 2024 Dec 4.

    PubMed 39637767

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 409306 in people with Schizophrenia, run by Boehringer Ingelheim at 59 sites in 7 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 18 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: stopped early, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Japan, Canada, France, South Korea and 2 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 4 Apr 2022). 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?

Incidence Rate of First Relapse After 28 Weeks of Treatment (time frame: 28 weeks). 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 NCT03351244, which also lists 1 linked publication.

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 14 May 2025.

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