This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year

NCT ID: NCT03230097

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-29
• Study Completion Date: 2021-04-07

Brief Summary

This is a study in people between 16 and 30 years of age who have a specific type of mental illness called attenuated psychosis syndrome (APS). The purpose of this study is to find out whether BI 409306 helps reduce the symptoms of APS.

Participants are in the study for 1 year and 2 months. During this time, they visit the study site about 15 times and get about 10 phone calls. Participants are put into 2 groups by chance. They get either BI 409306 or placebo. Placebo tablets look like BI 409306 tablets but do not contain any medicine. Participants take a BI 409306 or placebo tablet two times a day.

During the study, participants answer questions in interviews and complete questionnaires so the doctors can check whether the APS symptoms change. The doctors also check the general health of the participants.

Conditions

Psychotic Disorders

Study Design

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

Study Groups

BI 409306

Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Group Type: EXPERIMENTAL

BI 409306

Intervention Type: DRUG

50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Placebo

Patients meeting Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnostic criteria for attenuated psychosis syndrome (APS) per the Structured Interview for Psychosis-Risk Syndromes (SIPS) took placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Interventions

BI 409306

50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Intervention Type: DRUG

Placebo

placebo matching 50 milligrams BI 409306, as a film-coated tablet, orally twice a day at approximately the same time every day in the morning and in the evening (approximately 12 hours apart) with or without food for 52 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meet diagnostic criteria for attenuated psychosis syndrome as defined in DSM-5 and determined by SIPS administered at screening and diagnosis confirmed by NeuroCog Trials after review of video-taped SIPS interview.
• Age ≥16 and ≤ 30 years at the time of consent/assent.
• Male or female patients willing to use highly effective methods of contraception.

• Female patients of childbearing potential must be ready and able to use highly effective methods of birth control per 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 Good Clinical Practice (GCP) and local legislation prior to any study-related procedures OR signed and dated informed consent provided by the patient's parent(s) (or legal guardian) and assent by the patient prior to any study-related procedures in accordance with GCP and local legislation. If the patient has a legal representative, then this legal representative must give written informed consent as well.

Exclusion Criteria

• Present or past diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder I, major depressive disorder with psychotic features, delusional disorder, brief psychotic disorder, other specified schizophrenia spectrum and other psychotic disorder (except attenuated psychosis syndrome), and unspecified schizophrenia spectrum and other psychotic disorder, according to DSM-5.
• Patients taking antipsychotic medication for less than 8 weeks, or patients taking antipsychotic medication for a longer duration but who have not been on a stable dose for 8 weeks prior to informed consent.
• Patients who begin taking an antipsychotic between Visit 1 and Visit 2.
• Patients who have discontinued an antipsychotic medication less than two weeks prior to randomization.
• Patients taking Clozapine.
• Suicidal behavior in the past 2 years reported in the Columbia Suicide Severity Rating Scale (C-SSRS) with a lethality of attempt ≥1, or with a lethality of 0 but a potential lethality of 2, or that in the judgement of the investigator would jeopardize the patient's safety while participating in the trial. The investigator/qualified rater must review all screening C-SSRS reports prior to randomization, documenting an additional interview assessing lethality of the behavior history when appropriate.
• 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.
• Known diseases of the central nervous system (including but not limited to any kind of seizures or stroke).
• History of significant head injury (>5 minutes without consciousness).
• A serious developmental disorder that in the judgement of the investigator would inhibit the patient's ability to comply with all study procedures, or mental retardation (documented IQ <70), or acute attenuated symptoms exclusively related to intoxication from a psychotropic substance.
• 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.
• Meets criteria for Substance Use Disorder (DSM-5) within the six months prior to informed consent/assent.
• 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 a strong or moderate inhibitor 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 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 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
• Previous participation in any BI 409306 study.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

ProScience Research Group

Culver City, California, United States

University of California San Diego

San Diego, California, United States

PRIME Clinic

New Haven, Connecticut, United States

University of Florida College of Medicine

Jacksonville, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Augusta University

Augusta, Georgia, United States

Boston Medical Center

Boston, Massachusetts, United States

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Cherry Health

Grand Rapids, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

Altea Research Institute

Las Vegas, Nevada, United States

Center For Emotional Fitness

Cherry Hill, New Jersey, United States

New York State Psychiatric Institute

New York, New York, United States

Finger Lakes Clinical Research

Rochester, New York, United States

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

PeaceHealth Medical Group

Eugene, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Community Clinical Research, Inc.

Austin, Texas, United States

University Hills Clinical Research

Irving, Texas, United States

Psychiatric and Behavioral Solutions, LLC

Salt Lake City, Utah, United States

University of Calgary

Calgary, Alberta, Canada

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta, Canada

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, Canada

Alan D. Lowe Medicine Professional Corporation

Toronto, Ontario, Canada

Peking University Sixth Hospital

Beijing, , China

Shanghai Mental Health Center

Shanghai, , China

Holywell Hospital

Antrim, , United Kingdom

The Barberry National Centre for Mental Health

Birmingham, , United Kingdom

King's College Hospital

London, , United Kingdom

University of Manchester

Manchester, , United Kingdom

Countries

United States; Canada; China; United Kingdom

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)

Keefe RSE, Woods SW, Cannon TD, Ruhrmann S, Mathalon DH, McGuire P, Rosenbrock H, Daniels K, Cotton D, Roy D, Pollentier S, Sand M. A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale. Early Interv Psychiatry. 2021 Oct;15(5):1315-1325. doi: 10.1111/eip.13083. Epub 2020 Dec 22.

Reference Type: DERIVED

PMID: 33354862 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.mystudywindow.com

Related Info

Other Identifiers

2016-004973-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1289.32

Identifier Type: -

Identifier Source: org_study_id