Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Double-blind Controlled Trial to Assess the Benefits of Olanzapine and Amisulpride Combination Treatment in Acutely Ill Schizophrenia Patients. - COMBINE
Brief Summary: A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.


Options:
A: Inclusion Criteria:

* patients featuring psychomotor agitation, with clinical need for intramuscular injection

Exclusion Criteria:

* delirium, severe or unstable general medical condition, previous history of severe adverse effects with one of the treatment options
B: Inclusion Criteria:

* Patients with schizophrenia and schizoaffective disorder according to International Classification of Diseases (ICD-10);
* age 18-65;
* Positive and Negative Symptom Scale Total-Score ≥ 70 and two items of the positive symptom subscale ≥4.
* voluntary treatment after written informed consent
* legal capacity
* exclusion of pregnancy by laboratory test (Beta HCG)

Exclusion Criteria:

* participation in other interventional studies with drugs or medical devices
* first episode patients
* physical disease that might have effects on the conduct or evaluation of the trial
* contraindications to medication according to experts information
* oversensitivity to active substance or other component of the drugs used
* known clozapine resistance
* suicidal ideation
* pregnancy or lactation
* which of pregnancy or absence save contraception
* dependency to sponsor or investigator
* institutionalization through judicial or regulatory order
* oversensitivity to placebo (mannite/aerosil)
C: Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* Current clozapine treatment
* Moderate illness severity and inadequate positive symptom response to clozapine treatment
* 6 month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

Exclusion Criteria:

* Organic brain disorder
* Mental retardation
* Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
* Pregnancy
* DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month
* Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks
D: Inclusion criteria:

* SCID diagnosis of schizophrenia or schizoaffective disorder
* Partially remitted outpatients, defined as persons who have received clear symptomatic benefit from antipsychotic medication but remain symptomatic (due to lack of efficacy or inability to tolerate an efficacious dose) or suffer significant side effects
* Treatment with antipsychotic medications for at least 2 months
* Received at least 1 outpatient mental health service every 3 months for the past 6 months

Exclusion criteria:

* Severe symptoms or side effects that indicate the necessity for a medication change
* Currently taking 3 or more antipsychotic medications for ongoing daily administration (PRN medications and mood stabilizers are allowable)
* Treatment with clozapine
* One or more nights spent in a psychiatric hospitalization within the past 3 months
* Received services from a crisis intervention program within the past 3 months
* Require placement in a skilled nursing facility as a result of a physical condition or disability
* Criminal charges pending (once charges clear, the person will be considered)
* Pregnant or breast feeding
* Contraindication to any of the medications to which the patient might be assigned

Answer: B