Age
Item
males or females aged >/= 18 years and </= 60 years
boolean
C0001779 (UMLS CUI [1])
Stable status Clinical | Schizophrenia Mild | Schizophrenia Moderate
Item
clinically stable, mild or moderate schizophrenia
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0036341 (UMLS CUI [2,1])
C2945599 (UMLS CUI [2,2])
C0036341 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
Antipsychotic drug therapy Stable
Item
on stable antipsychotic treatment for the last 6 months
boolean
C1319421 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
General health good Medical History | General health good Physical Examination | General health good Vital signs | General health good Electrocardiography | General health good Hematology | General health good Clinical Chemistry Tests | General health good Urinalysis | General health good Serologic tests | General health good Laboratory Procedures
Item
generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ecg), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0518766 (UMLS CUI [3,2])
C1277245 (UMLS CUI [4,1])
C1623258 (UMLS CUI [4,2])
C1277245 (UMLS CUI [5,1])
C0200627 (UMLS CUI [5,2])
C1277245 (UMLS CUI [6,1])
C0525044 (UMLS CUI [6,2])
C1277245 (UMLS CUI [7,1])
C0042014 (UMLS CUI [7,2])
C1277245 (UMLS CUI [8,1])
C0036743 (UMLS CUI [8,2])
C1277245 (UMLS CUI [9,1])
C0022885 (UMLS CUI [9,2])
Hospitalization Duration Willing
Item
willingness to be hospitalized for approximately 3 weeks
boolean
C0019993 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Body mass index
Item
bmi > 18.5 kg/m2 and < 38 kg/m2
boolean
C1305855 (UMLS CUI [1])
Contraceptive methods | Gender Sperm donation Absent | Gender Pregnancy Absent | Gender Breast Feeding Absent
Item
use of highly effective contraception as defined by the study protocol. men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding
boolean
C0700589 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0871414 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0032961 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0006147 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Antiparkinson Agents | Anticholinergic Agents
Item
treatment with antiparkinson medication including anticholinergic drugs
boolean
C0003405 (UMLS CUI [1])
C0242896 (UMLS CUI [2])
Injection of depot antipsychotic agent
Item
treatment with depot antipsychotic medication within the last three months prior to screening
boolean
C2585377 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
participation in a clinical trial with an investigational drug or device < 3 months prior to screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Tobacco use Number of cigarettes per day
Item
smokes more than 20 cigarettes per day
boolean
C0543414 (UMLS CUI [1,1])
C3694146 (UMLS CUI [1,2])
Drug abuse | Exception Nicotine abuse
Item
current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit
boolean
C0013146 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2363943 (UMLS CUI [2,2])
Blood Donation | Blood Loss Significant
Item
any donation of blood or significant blood loss within three months prior to first administration of the study drug
boolean
C0005794 (UMLS CUI [1])
C3163616 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
Illicit medication use | Vitamins Illicit | Herbal medicine (product) Illicit
Item
use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration
boolean
C0281875 (UMLS CUI [1])
C0042890 (UMLS CUI [2,1])
C0332266 (UMLS CUI [2,2])
C2240391 (UMLS CUI [3,1])
C0332266 (UMLS CUI [3,2])