Eligibility Major Depressive Disorder NCT02366364

1 moduli

StudyEvent: Eligibility
1. Eligibility Major Depressive Disorder NCT02366364

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Gender

Item

male and female subjects

boolean

C0079399 (UMLS CUI [1])

Age

Item

aged 18 to 55 years

boolean

C0001779 (UMLS CUI [1])

Female Sterilization | Menopause | Contraceptive methods | Childbearing Potential pregnancy blood test Negative | Childbearing Potential Urine pregnancy test negative

Item

for female subjects, surgically sterile or at least 2 years menopausal, or using an acceptable method of birth control. if of childbearing potential, have a documented negative blood or urine pregnancy test within 24 hours prior to dosing.

boolean

C0015787 (UMLS CUI [1])
C0025320 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0850355 (UMLS CUI [4,2])
C0205160 (UMLS CUI [4,3])
C3831118 (UMLS CUI [5,1])
C0430057 (UMLS CUI [5,2])

Laboratory Procedures | Upper Limit of Normal | Clinical Significance

Item

clinical laboratory values <2 times upper limit of normal (uln) or deemed not clinically significant by the investigator

boolean

C0022885 (UMLS CUI [1])
C1519815 (UMLS CUI [2])
C2826293 (UMLS CUI [3])

Compliance behavior Study Protocol | Informed Consent

Item

ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments

boolean

C1321605 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

HIV Infections | Hepatitis | Communicable Diseases

Item

human immunodeficiency virus (hiv) infection, or hepatitis or other ongoing infectious disease.

boolean

C0019693 (UMLS CUI [1])
C0019158 (UMLS CUI [2])
C0009450 (UMLS CUI [3])

Alcohol abuse | Beer | Wine | Spirits

Item

current evidence of alcohol abuse (greater than 4 units of alcohol on most days; 1 unit = 1/2 pint of beer, 1 glass of wine or 1 oz. of spirits), or in the option of the investigator that subject may be alcoholic.

boolean

C0085762 (UMLS CUI [1])
C2107808 (UMLS CUI [2])
C2203276 (UMLS CUI [3])
C0301611 (UMLS CUI [4])

Substance Use Disorders DSM-IV

Item

current abuse of illicit substances, using the diagnostic and statistical manual (dsm) iv definition of drug abuse.

boolean

C0038586 (UMLS CUI [1,1])
C0220952 (UMLS CUI [1,2])

Current Smoker | Tobacco use

Item

current smoker or use of other tobacco products.

boolean

C3241966 (UMLS CUI [1])
C0543414 (UMLS CUI [2])

Pregnancy | Pregnancy, Planned | Breast Feeding

Item

currently pregnant, planning to become pregnant during the course of the study, or nursing mother.

boolean

C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Item

type i or type ii diabetes.

boolean

C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])

Malignant Neoplasms | Basal cell carcinoma | Squamous cell carcinoma of skin | Carcinoma in situ of uterine cervix

Item

malignancy in the last 5 years, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.

boolean

C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
C0851140 (UMLS CUI [4])

Take prescription medications | Take non-prescription medications | Phytotherapy

Item

currently taking prescription or over-the-counter medications including herbal therapies, within 14 days of enrollment into the study.

boolean

C3843193 (UMLS CUI [1])
C3843194 (UMLS CUI [2])
C0242388 (UMLS CUI [3])

Item

history of allergy, sensitivity, or intolerance to nmdar ligands including ketamine, dextromethorphan, memantine, methadone, dextropropoxyphene, or ketobemidone or concomitant use of such agents.

boolean

C0020517 (UMLS CUI [1,1])
C0080093 (UMLS CUI [1,2])
C0023688 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0080093 (UMLS CUI [2,2])
C0023688 (UMLS CUI [2,3])
C0022614 (UMLS CUI [3])
C0011816 (UMLS CUI [4])
C0025242 (UMLS CUI [5])
C0025605 (UMLS CUI [6])
C0033493 (UMLS CUI [7])
C0064311 (UMLS CUI [8])

Investigational New Drugs Other | Investigational Medical Device Other

Item

received another investigational drug or device within 30 days of enrollment in this study.

boolean

C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2346570 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])

Study Subject Participation Status

Item

previously participated in this study.

boolean

C2348568 (UMLS CUI [1])

Item

psychiatric disease including major depression, bipolar disorder, anxiety, or schizophrenia, or other medical condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug safety. 13) in the option of the investigator or the sponsor's study monitor, has a history of severe renal or hepatic impairment, severe active hepatic disease, or other clinically significant medical condition that may preclude safe study participation.

boolean

C0004936 (UMLS CUI [1])
C1269683 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
C0003467 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
C1699700 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0013175 (UMLS CUI [6,3])
C1565489 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0948807 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0023895 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C1699700 (UMLS CUI [10,1])
C2348568 (UMLS CUI [10,2])
C0439801 (UMLS CUI [10,3])

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Eligibility Major Depressive Disorder NCT02366364