Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine or Risperidone Monotherapy.
Brief Summary: A Multicenter, Double-blind 16 Week Study on the augmentation of atypical antipsychotic with Aripiprazole in patients with Schizophrenia with inadequate response to antipsychotic treatment.


Options:
A: 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)
B: Inclusion Criteria:

* Diagnosis of schizophrenia according to DSM-IV criteria
* Any schizoaffective disorder or subtype
* Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)
* Currently taking clozapine
* Score of four or higher on two or more items from the positive symptom subscale of the PANSS
* Score of 4 or greater on the Clinical Global Impression (CGI) scale
* Clozapine plasma level greater than 378 µg/ml
* Stable dose of clozapine demonstrated to have been associated with a clozapine plasma level greater than 378 µg/ml for at least eight weeks
* Able to read at an 8th grade level or above

Exclusion Criteria:

* History of unstable coronary artery disease
* Congestive heart failure
* History of long Q-T syndrome
* History of cardiac arrhythmia
* History of cardiac conduction delay
* Baseline QT correction score greater than 0.425 seconds
* Liver disease
* History of stroke
* History of Neuroleptic Malignant Syndrome
* Hypokalemia
* Hypocalcemia
* Current blindness, deafness, language difficulties, or any other disability which may prevent participation or cooperation in the study
* Current suicidal or homicidal thoughts
* Currently abusing psychoactive substances
* Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not criteria for exclusion)
C: Inclusion Criteria:

* Patient with diagnosis of chronic Schizophrenia or Schizoaffective disorder
* Stable symptoms and dose of Quetiapine or Risperidone

Exclusion Criteria:

* First diagnosis in the past year
* Significant risk of suicide or meet DSM-IV-TR criteria for substance abuse
D: Inclusion Criteria:

* Subjects treated with clozapine for the indication of poor response to other antipsychotic medications.
* Treatment with clozapine is at a stable dose for at least 12 weeks. Dose must be 400 mg/day or more, unless side effects limited increase of dose.

Exclusion Criteria:

* Subjects with significant alcohol or substance abuse in the past 3 months.
* Subjects with a previous trial of risperidone augmentation of clozapine
* Subjects who are pregnant, breast-feeding, or women of child-bearing potential not using adequate contraception
* Subjects requiring treatment with anticonvulsants.
* Subjects with known hypersensitivity or allergy to risperidone.
* Subjects with hematological or other contraindications to continued clozapine treatment.

Answer: C