Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Impact of Early Medication Discontinuation on Long-term Clinical Outcome in First Episode Psychosis
Brief Summary: The study aims to examine the relationship between early maintenance therapy decisions in first episode psychosis, and the subsequent long-term clinical outcome at 9-10 years by comparing a group of patients who were randomized to discontinue (placebo) or continue medication (quetiapine) in the early stage of their psychotic disorders.


Options:
A: Inclusion Criteria:

* Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening.
* Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.
* Subjects who are currently being treated with oral or depot antipsychotics other than clozapine.
* Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Exclusion Criteria:

* Subjects with a current DSM-IV-TR diagnosis other than schizophrenia.
* Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).
* Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or subjects who were on a stimulant treatment for any period of time over the last one year prior to screening.
* Subjects with any neurodevelopmental disorder, except Tourette's syndrome.
* Subjects experiencing acute depressive symptoms within the past 30 days prior to screening.
* Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
* Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.
* Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism or hyperthyroidism (unless the condition has been stabilized with medication for at least 90 days prior to entry into Phase 1 or Phase 2).
* Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels.
B: Inclusion criteria:

1. Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)) with the following clinical features:

   1. Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks.
   2. Maintained on current antipsychotic medications and current dose for at least 8 weeks.
   3. Have no more than a moderate severity rating on hallucinations and delusions (e.g. Brief Psychiatric Rating Scale (BPRS) Hallucinatory Behavior or Unusual Thought Content item score \< or =4).
   4. Have no more than a moderate severity rating on positive formal thought disorder (e.g. BPRS Conceptual Disorganization item score \< or =4).
   5. Have no more than a moderate severity rating on negative symptoms (Positive and Negative Syndrome Scale negative syndrome total score \<15).
   6. Have a minimal level of extrapyramidal symptoms (e.g. Simpson-Angus Scale total score \< 6) and depressive symptoms (e.g. Calgary Depression Scale total score \< 10).
2. Male or female patients age \> or = 18 and \< or =55 years.
3. Patients must exhibit reliability and physiologic capability to comply with all protocol procedures.
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written consent as well.

Exclusion criteria:

1. Patient treated with more than one antipsychotic or not stabilized on antipsychotic treatment, or having had electroconvulsive therapy within the last 30 days
2. Patient's cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator.
3. Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
4. Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
5. Any finding of the medical examination (including BP, PR and ECG) or laboratory value deviating from normal and of clinical relevance in the judgment of the investigator.
6. Any evidence of a clinically relevant concomitant disease.
7. History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, haematological or hormonal disorders.
8. Female patients that are of child-bearing potential or currently breastfeeding.
9. Known history, or new diagnosis per screening labs, of HIV infection.
10. History of neurologic (e.g. stroke, seizure without a clear and resolved etiology, concussion accompanying loss of consciousness) or psychiatric condition that the investigator deems may interfere with interpretability of data
11. History of malignancy within the last 5 years, except for basal cell carcinoma.
12. Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day during the study period.
13. Any other clinical condition that, in the opinion of the investigator, would jeopardize a patient's safety while participating in this clinical trial.
14. Significant history of drug dependence or abuse (including alcohol, as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, phencyclidine (PCP), amphetamine or marijuana at screening.
15. Participation in another trial with an investigational drug or procedure within 30 days prior to screening or previous participation in any BI 409306 study.
C: Inclusion Criteria:

* A diagnosis of schizophrenia or non-affective psychosis (schizophreniform disorder, schizoaffective disorder, brief psychotic disorder, or psychosis not otherwise specified) (DSM-IV)
* Aged 18 to 65 years
* Had been treated with antipsychotic drugs for at least 12 months
* No history of relapse or exacerbation or had to be asymptomatic (free of positive symptoms of psychosis) at study entry.

Exclusion Criteria:

* A diagnosis of drug-induced psychosis
* Current treatment with clozapine, with mood stabilizing medications (lithium, valproate or carbamazepine) or with depot medication
* Had high risk of suicide or violence
* Had poor adherence to treatment (missing\>50% of drug, \>50% missed clinic visits, or a history of medication discontinuation)
D: Inclusion Criteria:

* Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening
* have a PANSS score of \<120
* have a body mass index (BMI) \>/=15.0 kilogram (kg)/meter (m)2
* and have resided at the same address for at least 30 days

Exclusion Criteria:

* Patients unable to provide their own consent
* have been involuntarily committed to psychiatric hospitalization
* have primary, active DSM-IV-TM diagnosis other than schizophrenia
* who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications
* have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water
* have a history of neuroleptic malignant syndrome (NMS)
* are at significant risk of suicidal or violent behavior
* current presence of any significant or unstable medication condition
* treatment with any protocol disallowed therapies
* clinically significant result from screening laboratory or ECG.

Answer: C