Informed Consent
Item
1. capable of providing informed consent.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male or female aged ≥18 years to ≤65 years.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
3. current diagnosis of schizophrenia, according to diagnostic and statistical manual
boolean
C0036341 (UMLS CUI [1])
Body mass index
Item
4. body mass index (bmi) ≥17 kg/m2 but ≤35 kg/m2.
boolean
C1305855 (UMLS CUI [1])
Stable status Medical | Stable status Psychiatric
Item
5. medically stable over the last month, and psychiatrically stable
boolean
C0205360 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0205360 (UMLS CUI [2,1])
C0205487 (UMLS CUI [2,2])
Risperidone Dose Stable U/day | Maintenance therapy
Item
6. on oral stable dosage of risperidone ≥4 mg daily as maintenance therapy.
boolean
C0073393 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0456683 (UMLS CUI [1,4])
C0677908 (UMLS CUI [2])
PANSS Clinical Classification
Item
7. total score ≤70 on the positive and negative syndrome scale.
boolean
C4086747 (UMLS CUI [1])
Use of Contraceptive method
Item
8. using a medically accepted contraceptive method
boolean
C1524063 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Washout Illicit medication
Item
9. agrees to washout all prohibited medications prior to baseline (day -1)
boolean
C1710661 (UMLS CUI [1,1])
C0281875 (UMLS CUI [1,2])
Informed Consent Third Party
Item
1. informed consent obtained from a third party.
boolean
C0021430 (UMLS CUI [1,1])
C1698594 (UMLS CUI [1,2])
Prisoners
Item
2. prisoners or patients who are compulsorily detained.
boolean
C0033167 (UMLS CUI [1])
Breast Feeding | Pregnancy test positive
Item
3. females who are breast-feeding and/or who have a positive pregnancy test.
boolean
C0006147 (UMLS CUI [1])
C0240802 (UMLS CUI [2])
Medical condition Unstable Uncontrolled
Item
4. presence of an uncontrolled, unstable clinically significant medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Serology positive Hepatitis B | Serology positive Hepatitis C | Serology positive HIV-1 antibody | Serology positive HIV-2 antibody
Item
5. positive serology for hepatitis b, hepatitis c or anti-hiv 1 and 2 at screening.
boolean
C0242089 (UMLS CUI [1,1])
C0019163 (UMLS CUI [1,2])
C0242089 (UMLS CUI [2,1])
C0019196 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0369497 (UMLS CUI [3,2])
C0242089 (UMLS CUI [4,1])
C0369500 (UMLS CUI [4,2])
Neuroleptic Malignant Syndrome
Item
6. history of neuroleptic malignant syndrome.
boolean
C0027849 (UMLS CUI [1])
Tardive Dyskinesia
Item
7. current or past history of tardive dyskinesia.
boolean
C0686347 (UMLS CUI [1])
Urine drug screen positive | Alcohol Screen Positive
Item
8. positive urine drug or alcohol screen finding.
boolean
C0743300 (UMLS CUI [1])
C0001962 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
At risk for deliberate self harm Columbia suicide severity rating scale
Item
9. risk of committing self-harm or harm based on columbia suicidal rating scale.
boolean
C1276053 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
Antidepressive Agents Quantity
Item
10. taking more than one antidepressant.
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Depot Antipsychotic Agents
Item
11. use of depot antipsychotics within the last three months.
boolean
C0086129 (UMLS CUI [1,1])
C0040615 (UMLS CUI [1,2])
CYP3A4 Inducers Strong | CYP3A4 Inducers Moderate
Item
12. use of strong or moderate cytochrome p450 isoenzyme 3a4inducers
boolean
C3850041 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850041 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Electroconvulsive Therapy
Item
13. use of electroconvulsive therapy (ect) within the last three months.
boolean
C0013806 (UMLS CUI [1])
Investigational New Drugs
Item
14. receipt of any investigational drugs within the last three months.
boolean
C0013230 (UMLS CUI [1])
Risperidone allergy | Risperidone allergy Suspected
Item
15. known or suspected allergy or hypersensitivity to risperidone
boolean
C0570837 (UMLS CUI [1])
C0570837 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Risperidone Therapy non-responder Previous
Item
16. previous non-responder to risperidone treatment.
boolean
C0073393 (UMLS CUI [1,1])
C0919875 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])