Postmenopausal state | Female Sterilization | Gender Sexually active Contraceptive methods | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Vaginal Spermicides | Condom | Gender Serum pregnancy test (B-HCG) Negative
Item
female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device [iud- an intrauterine device made of plastic and/or copper that is inserted into the womb [uterus] by way of the vaginal canal to used to prevent pregnancy], diaphragm with spermicide [agent that kills spermatozoa] or condom [cover worn over the penis during sexual intercourse to prevent infection or pregnancy] with spermicide) throughout the study and have a negative serum beta - human chorionic gonadotropin (hcg) pregnancy test at screening
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0042241 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0677582 (UMLS CUI [8])
C0079399 (UMLS CUI [9,1])
C0430060 (UMLS CUI [9,2])
C1513916 (UMLS CUI [9,3])
Risperidone Oral Daily Dose
Item
participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study
boolean
C0073393 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2348070 (UMLS CUI [1,3])
Risperidone | Partial therapeutic response | Symptoms Persistent | Clinical status Unstable | Side effects Severe
Item
participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects
boolean
C0073393 (UMLS CUI [1])
C1275833 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0449440 (UMLS CUI [4,1])
C0443343 (UMLS CUI [4,2])
C0879626 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Change Atypical antipsychotic Other | Etiology Clinical Response | Etiology Side effects
Item
potential participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.
boolean
C0392747 (UMLS CUI [1,1])
C1276996 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C4055223 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0879626 (UMLS CUI [3,2])
Mental disorders | Exception Schizophrenia
Item
participants with past or current history of psychiatric disease other than schizophrenia according to diagnostic and statistical manual of mental disorders (dsm)-iv
boolean
C0004936 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
Comorbidity Severe | Comorbidity Life Threatening | Nervous system disorder Severe | Nervous system disorder Life Threatening | At risk for suicide
Item
participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0027765 (UMLS CUI [4,1])
C2826244 (UMLS CUI [4,2])
C0563664 (UMLS CUI [5])
Clozapine
Item
participants previously using clozapine
boolean
C0009079 (UMLS CUI [1])
Antipsychotic Agents Oral Unresponsive to Treatment
Item
participants with a history of previous non-responsiveness to oral antipsychotic treatment
boolean
C0040615 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding female participants
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])