Criteria Fulfill Schizophrenia
Item
participant meets the diagnostic and statistical manual of mental disorders (edition 4) criteria for schizophrenia
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0036341 (UMLS CUI [1,3])
Antipsychotic Agents Schizophrenia | CGI - Severity of Illness | Oral antipsychotic therapy | Prior Therapy Unsuccessful | Lack of Efficacy | Intolerance to substance | Lack Safety | Compliance behavior Lacking
Item
participant is previously non-acute (on the same antipsychotic medication used for the treatment of schizophrenia and clinical global impression-severity [cgi-s] change less than or equal to 1 in the past 4 weeks before enrollment) and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
boolean
C0040615 (UMLS CUI [1,1])
C0036341 (UMLS CUI [1,2])
C3639887 (UMLS CUI [2])
C4273790 (UMLS CUI [3])
C1514463 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0235828 (UMLS CUI [5])
C1744706 (UMLS CUI [6])
C0332268 (UMLS CUI [7,1])
C0036043 (UMLS CUI [7,2])
C1321605 (UMLS CUI [8,1])
C0332268 (UMLS CUI [8,2])
Healthy Volunteer Physical Examination | Healthy Volunteer Vital signs
Item
participant is healthy on the basis of a physical examination and vital signs at screening
boolean
C1708335 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C1708335 (UMLS CUI [2,1])
C0150404 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Gender Sexual Abstinence | Gender Sexually active Contraceptive methods
Item
female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0241028 (UMLS CUI [4,2])
C0700589 (UMLS CUI [4,3])
Questionnaires Self-Administered Completion
Item
participants must be willing and able to fill out self-administered questionnaires
boolean
C0034394 (UMLS CUI [1,1])
C1519231 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Clozapine | Depot neuroleptic | Risperidone Injection Active Long-term
Item
participants on clozapine, any conventional depot neuroleptic or risperidone long-acting injection during the last 3 months
boolean
C0009079 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0086129 (UMLS CUI [2,2])
C4084406 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
Medical condition Unstable Serious | Laboratory test result abnormal
Item
participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2])
Tardive Dyskinesia | Symptoms Tardive Dyskinesia | Neuroleptic Malignant Syndrome | High fever | Rigid muscle | Tremor | Confusion | Increased sweating | Tachycardia | Increase in blood pressure | Myalgia | Muscle Weakness
Item
participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
boolean
C0686347 (UMLS CUI [1])
C1457887 (UMLS CUI [2,1])
C0686347 (UMLS CUI [2,2])
C0027849 (UMLS CUI [3])
C0743973 (UMLS CUI [4])
C0555752 (UMLS CUI [5])
C0040822 (UMLS CUI [6])
C0009676 (UMLS CUI [7])
C0700590 (UMLS CUI [8])
C0039231 (UMLS CUI [9])
C0497247 (UMLS CUI [10])
C0231528 (UMLS CUI [11])
C0151786 (UMLS CUI [12])
High risk of Adverse events | High risk of Violence | High risk of Self-harm
Item
participants judged to be at high risk for adverse events, violence or self-harm
boolean
C0332167 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0042693 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0424366 (UMLS CUI [3,2])
Substance Dependence
Item
participants with a current use or known history (over the past 6 months) of substance dependence according to diagnostic and statistical manual of mental disorders (edition 4) criteria
boolean
C0038580 (UMLS CUI [1])