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

NCT03230097 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1289.322016-004973-42
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 33

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Remission From Attenuated Psychosis Syndrome (APS) Within a 52-week Timeframe

  Incidence of remission from attenuated psychosis syndrome (APS) within a 52-week timeframe. The incidence rate per patient-years of remission from attenuated psychosis syndrome (APS) is reported. Remission from APS is defined as a score of \<3 on all of the five Positive Symptom items of the Scale of Prodromal Symptoms (SOPS) and maintained until the end of treatment. The SOPS provides a 6-point scale (minimum of 0 and maximum of 6, higher score indicating worse symptoms) to quantitatively rate the severity of five attenuated positive symptoms. incidence rate = number of events/total time at risk \[patient-years\].

  Up to 52 weeks.

Secondary Outcomes (4)

• Incidence of First Episode of Psychosis

  Up to 52 weeks.

• Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Total Score After 24 and 52 Weeks of Treatment

  Baseline, week 24 and week 52.

• Change From Baseline in the Tablet Based Brief Assessment of Cognition (BAC App) Composite T Score After 52 Weeks of Treatment

  Baseline and week 52.

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Positive Items Score, Negative Items Score, and Total Score After 52 Weeks of Treatment

  Baseline and week 52.

Study Arms (2)

BI 409306

EXPERIMENTAL

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.

Drug: BI 409306

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

BI 409306 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.

BI 409306

Placebo 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.

Placebo

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (33)

ProScience Research Group

Culver City, California, 90230, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

PRIME Clinic

New Haven, Connecticut, 06519, United States

Location

University of Florida College of Medicine

Jacksonville, Florida, 32209, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Cherry Health

Grand Rapids, Michigan, 49503, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Center For Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

PeaceHealth Medical Group

Eugene, Oregon, 97401, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

Psychiatric and Behavioral Solutions, LLC

Salt Lake City, Utah, 84105, United States

Location

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta, T6G 2B7, Canada

Location

Chatham-Kent Clinical Trials Research Centre

Chatham, Ontario, N7L 1C1, Canada

Location

Alan D. Lowe Medicine Professional Corporation

Toronto, Ontario, L3R 1A3, Canada

Location

Peking University Sixth Hospital

Beijing, 100089, China

Location

Shanghai Mental Health Center

Shanghai, 200030, China

Location

Holywell Hospital

Antrim, BT41 2RJ, United Kingdom

Location

The Barberry National Centre for Mental Health

Birmingham, B15 2SJ, United Kingdom

Location

King's College Hospital

London, SE5 8AF, United Kingdom

Location

University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39637767 DERIVED

• 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.

  PMID: 33354862 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psychotic Disorders

Interventions

BI 409306

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

The sponsor decided to prematurely stop enrollment. This decision was based on the unfortunate inability to meet expected enrolment goals, a situation made far worse by the impact of the COVID-19 pandemic.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 26, 2017
• Study Start: September 29, 2017
• Primary Completion: March 17, 2021
• Study Completion: April 7, 2021
• Last Updated: May 14, 2025
• Results First Posted: June 29, 2022

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (23); GB (4); CN (2); CA (4)