Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered BI 409306 During a 52-week Treatment Period as an Early Intervention in Patients With Attenuated Psychosis Syndrome.
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.


Options:
A: Inclusion Criteria:

* Age 18-40 yrs.
* Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):

  * Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year.
  * Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year.
  * Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year.
* Provided informed consent.

Exclusion Criteria:

* Past history of a treated or untreated psychotic episode of one week's duration or longer
* Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use).
* Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome
* Currently receiving treatment with metylphenidate.
* Rejects providing informed consent.
B: Inclusion Criteria:

1. /written informed consent (for individuals under 18 written informed consent of at least one of the parents is required),
2. /age between 13 and 25 years,
3. /ARMS as classified by the PACE criteria (Yung et al., 1998)

PACE criteria for ARMS include one or more of following characteristics which must have occurred within the last 12 months:

* Frank psychotic symptoms \< 1 week (Transient psychosis group)
* Attenuated psychotic symptoms \> 1 week, \> 2 times per week
* Decline in global function (drop in GAF of \> 30%) plus family history of psychosis or individual has schizotypal personality disorder To operationalize PACE criteria duration and severity ratings of psychotic symptoms will be performed using the Positive and Negative Syndromes of Schizophrenia Scale (PANSS) (Kay et al., 1987) applying following cut-off scores, following Morrison et al (2002): Ad 1) Transient psychosis is defined with the presence of symptoms that score 4 or more on hallucinations, 4 or more on delusions, or 5 or more on conceptual disorganizations, last less than one week and resolve without antipsychotic medication. Ad 2) Attenuated psychotic symptoms are defined by the presence of symptoms that score 3 on delusions, 2-3 on hallucinations, 3-4 on suspiciousness or 3-4 on conceptual disorganization.

Exclusion Criteria:

1. /Acute suicidal behaviour, aggressive behaviour (PANSS hostility, suicidality = 7),
2. /Drug abuse that contributed decisively to the presentation of the index episode, (dependency on morphine, cocaine, amphetamine, but not THC),
3. /Alcohol abuse if considered as major problem,
4. /Epilepsy,
5. /Mental Retardation (IQ\<80),
6. /Pregnancy and lactation,
7. /Structural changes in MRI or CT scan (e.g., tumours), expect for enlargement of ventricles or sulci,
8. /Previous history of antipsychotic drug (\>1 week) or mood stabilizer treatment,
9. /Laboratory values more than 10% outside the normal range for transaminases, CRP or bleeding parameters,
10. /Individuals with organic brain syndrome,
11. /Individuals who are taking anticoagulants,
12. /Individuals who are taking omega 3 supplements, currently or within 8 weeks of being included in the trial,
13. /Individuals who have other, severe, intercurrent illness which in the opinion of the investigator may put them at risk or influence the results of the trial or affect ability to take part in the trial.
C: Inclusion Criteria:

* 18-45 years of age
* F2 diagnosis in ICD 10
* Address in Copenhagen, Frederiksberg or Aarhus
* Antipsychotic medication not exceeding 12 weeks
* Informed consent

Exclusion Criteria:
D: 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

Answer: D