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
Condition: Psychotic Disorders
MeSH terms: Psychotic Disorders
Intervention: BI 409306; Placebo
Intervention description: 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 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 MeSH terms: BI 409306
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 16 Years
Maximum age: 30 Years
Healthy volunteers: No

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.
    

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.

          -  Further exclusion criteria apply