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

NCT ID: NCT03351244

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 264 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-07
• Study Completion Date: 2021-03-31

Brief 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. The study is designed to show superiority of BI 409306 over placebo in preventing relapse of schizophrenia symptoms.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 409306 50 mg

1 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.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

28 week treatment period

BI 409306 25 mg

1 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.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

28 week treatment period

Placebo

1 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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

28 week treatment period

Interventions

BI 409306

28 week treatment period

Intervention Type: DRUG

Placebo

28 week treatment period

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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).
• 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.

Exclusion Criteria

• 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).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alea Research

Phoenix, Arizona, United States

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Collaborative Neuroscience Network, LLC (CNS)

Garden Grove, California, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Synergy East

Lemon Grove, California, United States

University of California Los Angeles

Los Angeles, California, United States

Excell Research Inc.

Oceanside, California, United States

Orange County Neuropsychiatric Research Center LLC

Orange, California, United States

Collaborative Neuroscience Network, LLC (CNS)

Torrance, California, United States

MD Clinical

Hallandale, Florida, United States

Reliable Clinical Research

Hialeah, Florida, United States

Meridien Research

Maitland, Florida, United States

Behavioral Clinical Research, Inc.

North Miami, Florida, United States

Meridien Research

Orlando, Florida, United States

Atlanta Center

Atlanta, Georgia, United States

Alam Medical Research, Inc.

Chicago, Illinois, United States

Lake Charles Clinical Trials LLC

Lake Charles, Louisiana, United States

Clinical Trials of America, LLC

Monroe, Louisiana, United States

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

St. Charles Psychiatric Associates & Midwest Research Group

Saint Charles, Missouri, United States

Arch Clinical Trials

St Louis, Missouri, United States

PsychCare Consultants Research

St Louis, Missouri, United States

Altea Research Institute

Las Vegas, Nevada, United States

Hassman Research Institute

Berlin, New Jersey, United States

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Manhattan Behavioral Medicine PLLC

New York, New York, United States

Community Clinical Research, Inc.

Austin, Texas, United States

University Hills Clinical Research

Irving, Texas, United States

Pillar Clinical Research, LLC

Richardson, Texas, United States

@Health Texas

Richmond, Texas, United States

University of Calgary

Calgary, Alberta, Canada

Dr. Alexander McIntyre Inc.

Penticton, British Columbia, Canada

The Medical Arts Health Research Group

Vancouver, British Columbia, Canada

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, Canada

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

IUSMM Institut Universitaire en Sante Mentale de Montreal

Montreal, Quebec, Canada

HOP la Colombière

Montpellier, , France

GHU Paris Psychiatrie et Neurosciences

Paris, , France

HOP Guillaume Régnier

Rennes, , France

HOP Nord

Saint-Priest-en-Jarez, , France

HOP Sainte Musse

Toulon, , France

Okehazama Hospital Fujita Kokoro Care Center

Aichi, Toyoake, , Japan

Fujita Health University Hospital

Aichi, Toyoake, , Japan

National Center for Global Health and Medicine Kohnodai Hospital

Chiba, Ichikawa, , Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, , Japan

Kuramitsu Hospital

Fukuoka, Fukuoka, , Japan

Soushu Hospital

Kanagawa, Atsugi, , Japan

Kishiro Mental Clinic

Kanagawa, Kawasaki, , Japan

Nara Medical University Hospital

Nara, Kashihara, , Japan

National Hospital Organization Hizen Psychiatric Medical Center

Saga, Kanzaki-gun, , Japan

National Center Neurology and Psychiatry

Tokyo, Kodaira, , Japan

Chonnam National University Hospital

Gwangju, , South Korea

Seoul National University Bundang Hospital

Seongnam, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

NCKUH

Tainan City, , Taiwan

Taoyuan Psychiatric Center

Taoyuan District, , Taiwan

Countries

United States; Canada; France; Japan; South Korea; Spain; Taiwan

References

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.

Reference Type: DERIVED

PMID: 39637767 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2017-002369-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1289-0049

Identifier Type: -

Identifier Source: org_study_id