Age
Item
1. adult men or women, 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Schizophrenia
Item
2. meet dsm-iv criteria for schizophrenia.
boolean
C0036341 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Contraceptive methods
Item
3. women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Atypical antipsychotic Dose Therapeutic | Clozapine | olanzapine | Risperidone | ziprasidone | aripiprazole | Seroquel | Dosage unchanged
Item
4. must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to clozapine olanzapine, risperidone, ziprasidone, aripiprazole, seroquel) with no major dose changes for at least 4 weeks.
boolean
C1276996 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0302350 (UMLS CUI [1,3])
C0009079 (UMLS CUI [2])
C0171023 (UMLS CUI [3])
C0073393 (UMLS CUI [4])
C0380393 (UMLS CUI [5])
C0299792 (UMLS CUI [6])
C0287163 (UMLS CUI [7])
C0178602 (UMLS CUI [8,1])
C0442739 (UMLS CUI [8,2])
Positive and negative syndrome scale | PANSS - Suspiciousness or Persecution
Item
5. a minimum panss total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the panss (suspiciousness/persecution) at screening.
boolean
C0451383 (UMLS CUI [1])
C4087067 (UMLS CUI [2])
Clinical global impression scale
Item
6. have a clinical global impressions-severity (cgi-s) scale score of at least 4 (moderately ill) at baseline.
boolean
C3639708 (UMLS CUI [1])
Able to communicate Research Personnel | Informed Consent
Item
7. must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
boolean
C2364293 (UMLS CUI [1,1])
C0035173 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Use of Nasal Spray
Item
8. must be able to use nasal spray.
boolean
C1524063 (UMLS CUI [1,1])
C0461725 (UMLS CUI [1,2])
Protocol Compliance
Item
9. must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
boolean
C0525058 (UMLS CUI [1])
Criteria Fulfill
Item
subjects will be excluded from the study of they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Pregnancy test negative Screening
Item
1. are pregnant or are breastfeeding (negative pregnancy test at screening).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0427780 (UMLS CUI [3,1])
C1710032 (UMLS CUI [3,2])
Drug abuse Urine drug screen
Item
2. a urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
boolean
C0013146 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Medical condition Interferes with Study Protocol
Item
3. any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Study Subject Participation Status Inappropriate
Item
4. are unsuitable in any way to participate in this study, in the opinion of the investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
DSM-IV Diagnosis | Exception Schizophrenia
Item
5. another current dsm-iv diagnosis other than schizophrenia.
boolean
C0220952 (UMLS CUI [1,1])
C0011900 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0036341 (UMLS CUI [2,2])
allowed
Item
permitted:
boolean
C0683607 (UMLS CUI [1])
SSRI Quantity | Taking medication to help sleep Dose Adequate | Diphenhydramine | zolpidem | zaleplon | Diazepam
Item
subjects on one ssri, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study.
boolean
C0360105 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2054158 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0012522 (UMLS CUI [3])
C0078839 (UMLS CUI [4])
C0251504 (UMLS CUI [5])
C0012010 (UMLS CUI [6])