Eligibility Depressive Disorder, Treatment-Resistant NCT01179009

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StudyEvent: Eligibility
1. Eligibility Depressive Disorder, Treatment-Resistant NCT01179009

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

gender; age

Item

1. males and females aged 18-65 years;

boolean

C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])

dsm iv; major depressive disorder

Item

2. diagnostic and statistical manual (dsm) iv diagnosis of major depressive disorder, recurrent, severe;

boolean

C0220952 (UMLS CUI [1])
C1269683 (UMLS CUI [2])

depression therapy refractory

Item

3. depression must be considered treatment refractory as defined by montgomery asberg depression rating scale (madrs) score of 22 or above which is consistent with other studies;

boolean

C0011581 (UMLS CUI [1,1])
C1846625 (UMLS CUI [1,2])

antidepressant agents

Item

4. on a stable dose of permitted antidepressant medication or no medication pre-infusion;

boolean

C0003289 (UMLS CUI [1])

medical history Psychotic Disorders

Item

5. not currently psychotic and no history of psychosis within the previous 12 months; psychosis reported in the distant past may not be exclusionary if brief, per pi's judgment;

boolean

C0262926 (UMLS CUI [1,1])
C0033975 (UMLS CUI [1,2])

hypersensitivity clonidine

Item

6. no history of significant clinical or intolerable side effects or complications from clonidine;

boolean

C0020517 (UMLS CUI [1,1])
C0009014 (UMLS CUI [1,2])

Contraception status

Item

7. if a female of child-bearing potential: not pregnant or breast feeding and agrees to use birth control during the time of pre-dosing and infusions; and

boolean

C0420837 (UMLS CUI [1])

informed consent

Item

8. able to give informed consent.

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

bipolar disorder; schizophrenia

Item

1. confirmed bipolar disorder, schizophrenia, or schizoaffective disorder;

boolean

C0005586 (UMLS CUI [1])
C0036341 (UMLS CUI [2])

substance abuse disorder

Item

2. current or recent substance abuse/dependence (or any lifetime recreational ketamine or pcp use);

boolean

C1537075 (UMLS CUI [1])

axis ii disorder; personality disorder; Schizophrenia

Item

3. any severe axis ii personality disorder or schizophrenia spectrum disorder that, in the pi's judgment, could confound diagnosis or adherence to treatment;

boolean

C0741358 (UMLS CUI [1])
C0031212 (UMLS CUI [2])
C0036341 (UMLS CUI [3])

Compliance behavior Limited Comorbidity

Item

4. the presence of any abnormal laboratory findings or serious medical disorder or condition that may, in the judgment of the pi, confound the assessment of relevant biologic measures or diagnoses including: clinically significant organ system dysfunction; significant and uncontrolled endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease; coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the sa or av node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e.g., chronic obstructive or restrictive pulmonary disease); after evaluation, anyone determined to have a potentially compromised airway that could be difficult to intubate; fever; bmi less than 14.5; or any medical condition known to interfere with cognitive performance; medication-related exclusions include memantine, or any medication that could be considered contraindicated ketamine;

boolean

C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

concomitant medication

Item

5. current treatment with any medication contraindicated with ketamine or clonidine;

boolean

C2347852 (UMLS CUI [1])

Ketamine abuse

Item

6. lifetime illegal use of pcp or ketamine; no clinical use of ketamine for past 3 months

boolean

C3824685 (UMLS CUI [1])

dsm-iv mental retardation

Item

7. meets dsm-iv criteria for mental retardation;

boolean

C0220952 (UMLS CUI [1,1])
C0025362 (UMLS CUI [1,2])

hospitalization

Item

8. currently hospitalized;

boolean

C0019993 (UMLS CUI [1])

suicidal; homicidal

Item

9. acutely suicidal or homicidal (i.e., in imminent danger with plan, urges and intent to harm oneself or others) including any prior serious attempts (e.g., those requiring hospitalization) at the pi's discretion;

boolean

C0438696 (UMLS CUI [1])
C0745031 (UMLS CUI [2])

pregnancy; lactating

Item

10. is pregnant or breast-feeding; unwilling to use birth control if female of child bearing potential

boolean

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

informed consent

Item

11. unable to provide informed consent.

boolean

C0021430 (UMLS CUI [1])

neuroimaging; mri; claustrophobia

Item

12. for participants in the neuroimaging subset: history of claustrophobia, serious head injuries, seizures disorder, developmental delays, pacemaker, metal implants, permanent metal piercings or anything else that would preclude having an mri.

boolean

C0679575 (UMLS CUI [1])
C0024485 (UMLS CUI [2])
C0008909 (UMLS CUI [3])

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Eligibility Depressive Disorder, Treatment-Resistant NCT01179009