gender, age, dsm-iv diagnosis of schizophrenia or schizoaffective disorder
Item
1. women and men aged 18-65 with dsm-iv diagnosis of schizophrenia or schizoaffective disorder by diagnostic interview and chart review.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0036341 (UMLS CUI [3,1])
C0220952 (UMLS CUI [3,2])
C0036337 (UMLS CUI [4,1])
C0220952 (UMLS CUI [4,2])
stable disease, stable dose of antipsychotic medication, no current active suicidal ideation
Item
2. clinically stable on a stable dose of antipsychotic medication for at least one month, no current active suicidal ideation.
boolean
C0677946 (UMLS CUI [1])
C0040615 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0678766 (UMLS CUI [2,3])
C0749133 (UMLS CUI [3])
informed consent
Item
3. competent to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
childbearing age, pregnancy test, contraception
Item
4. women of childbearing age must have a negative pregnancy test at screening and agree to use an approved form of contraception throughout the study.
boolean
C1960468 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032976 (UMLS CUI [1,3])
laboratory results normal for age and gender
Item
5. screening labs within normal limits for age and gender except for liver function tests as specified below.
boolean
C1254595 (UMLS CUI [1,1])
C0586624 (UMLS CUI [1,2])
C0079399 (UMLS CUI [1,3])
C0001779 (UMLS CUI [1,4])
bipolar disorder, dementia, neurodegenerative disease, organic mental disorder
Item
1. diagnosis of bipolar disorder, dementia, neurodegenerative disease, or other organic mental disorder.
boolean
C0005586 (UMLS CUI [1])
C0497327 (UMLS CUI [2])
C0524851 (UMLS CUI [3])
C0349095 (UMLS CUI [4])
epilepsy, cns tumor
Item
2. history of seizure disorder or cns tumor.
boolean
C0014544 (UMLS CUI [1])
C0085136 (UMLS CUI [2])
liver function
Item
3. liver function tests elevated over twice normal.
boolean
C0232741 (UMLS CUI [1])
bulimia, major depressive disorder
Item
4. bulimia, or major depressive disorder within the last 6 months.
boolean
C0006370 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
arrhythmia, cerebro-vascular or cardiovascular event, serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae
Item
5. life-threatening arrhythmia, cerebro-vascular, or cardiovascular event within 6 months. current serious unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease such that hospitalization for treatment of that illness is likely within the next 2 months. lifetime history of multiple head injuries with neurological sequelae or a single severe head injury with lasting neurological sequelae.
boolean
C0003811 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C1320716 (UMLS CUI [3])
C0443343 (UMLS CUI [4,1])
C0018799 (UMLS CUI [4,2])
C0443343 (UMLS CUI [5,1])
C0023895 (UMLS CUI [5,2])
C0443343 (UMLS CUI [6,1])
C0024115 (UMLS CUI [6,2])
C0443343 (UMLS CUI [7,1])
C0014130 (UMLS CUI [7,2])
C0443343 (UMLS CUI [8,1])
C0027765 (UMLS CUI [8,2])
C0443343 (UMLS CUI [9,1])
C0018939 (UMLS CUI [9,2])
C0451948 (UMLS CUI [10,1])
C0496161 (UMLS CUI [10,2])
C1282312 (UMLS CUI [11,1])
C0496161 (UMLS CUI [11,2])
investigational medication
Item
6. use of investigational medication within 30 days of enrollment.
boolean
C0013230 (UMLS CUI [1])
clozapine
Item
7. use of clozapine.
boolean
C0009079 (UMLS CUI [1])
substance use disorder other than nicotine or caffeine
Item
8. substance use disorder other than nicotine or caffeine in the last 6 months (by self report and salivary drug and alcohol screen).
boolean
C0038586 (UMLS CUI [1])
C0543414 (UMLS CUI [2])
C2006086 (UMLS CUI [3])
current risk of homicide or suicide
Item
9. posing a current risk of homicide or suicide.
boolean
C1948151 (UMLS CUI [1])