Eligibility Major Depressive Disorder NCT00533832

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StudyEvent: Eligibility
1. Eligibility Major Depressive Disorder NCT00533832

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

major depressive episode

Item

1. diagnosed with major depressive episode (mde)

boolean

C0024517 (UMLS CUI [1])

chronic, recurrent mdes

Item

2. chronic (>=2 years)or recurrent (>-=4) lifetime mdes

boolean

C0154409 (UMLS CUI [1])
C0520666 (UMLS CUI [2])

treatment

Item

3. resistant to >=2 treatments from different categories

boolean

C0087111 (UMLS CUI [1,1])
C0013203 (UMLS CUI [1,2])

psychotherapy

Item

4. completed >=6 weeks of psychotherapy

boolean

C0033968 (UMLS CUI [1])

hamilton rating scale

Item

5. score >=20 on 24-item hamilton rating scale of depression

boolean

C0451203 (UMLS CUI [1])

Item

6. iq >=70

boolean

C0456149 (UMLS CUI [1])

antidepressants

Item

7. stable on current antidepressant medication (no more than 5 antidepressant meds) or taking no antidepressant meds for >=4 weeks before visit b1

boolean

C0003289 (UMLS CUI [1])

antipsychotics, anticonvulsants

Item

8. stable on atypical antipsychotic and anticonvulsant medications as for item #7

boolean

C0040615 (UMLS CUI [1])
C0003286 (UMLS CUI [2])

age

Item

9. age >=18 amd <=80 years

boolean

C0001779 (UMLS CUI [1])

gender, pregnancy, contraception

Item

10. male or nonpregnant female adequately protected from conception.

boolean

C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0700589 (UMLS CUI [3])

compliance

Item

11. able to comply with testing and follow-up visits

boolean

C1321605 (UMLS CUI [1])

informed consent

Item

12. voluntarily signed informed consent

boolean

C0021430 (UMLS CUI [1])

lithium

Item

13. patients with bipolar disorder demonstrated a resistance to lithium treatment or has a medical contraindication to treatment with lithium or is known to be intolerant to lithium (not applicable to patients with mdd)

boolean

C0005586 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0023870 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0023870 (UMLS CUI [3,2])
C0013203 (UMLS CUI [4,1])
C0023870 (UMLS CUI [4,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

atypical depression, psychosis

Item

1. atypical depression at study entry or psychotic symptoms in any mde

boolean

C0154437 (UMLS CUI [1])
C0033975 (UMLS CUI [2])

schizophrenia, schizoaffective disorder, or delusional disorders

Item

2. history of schizophrenia, schizoaffective disorder, or delusional disorders

boolean

C0036341 (UMLS CUI [1])
C0036337 (UMLS CUI [2])
C0011251 (UMLS CUI [3])

rapid cycling bipolar disorder

Item

3. rapid cycling bopolar disorder

boolean

C0005586 (UMLS CUI [1])

comorbidity

Item

4. secondary diagnosis of, or signs of, delirium, dementia, amnestic, or other cognitive disorders

boolean

C0009488 (UMLS CUI [1])

antidepressants

Item

5. failed 7 or more antidepressant treatments

boolean

C0003289 (UMLS CUI [1])

suicide

Item

6. a. suicide attempt requiring medical attention within previous 12 months b. >=2 suicide attempts in the past 12 months c. cannot guarantee that will not implement suicide d. likely to attempt suicide within next 6 mon in investigator's opinion

boolean

C0038661 (UMLS CUI [1])

substance abuse

Item

7. alcohol or substance dependence within previous 12 months or abuse within previous 6 mon other than nicotine dependence or abuse

boolean

C0038586 (UMLS CUI [1])

cardiac disease

Item

8. history of myocardial infarction or cardiac arrest

boolean

C0018799 (UMLS CUI [1])

neurological disease

Item

9. other progressive neurological disease, significant central nervous system disease or injury, or cervical fracture that makes implantation difficult

boolean

C0027765 (UMLS CUI [1])

general anesthesia

Item

10. received general anesthesia with 390 days before enrollment.

boolean

C0002915 (UMLS CUI [1])

medication

Item

11. taken an investigational drug within a clearance duration of 5 x the half-life of the investigational drug or within <=4weeks before visit b1, whichever time is greater

boolean

C0013227 (UMLS CUI [1])
C2348568 (UMLS CUI [2])

study subject participation status

Item

12. enrolled in another investigational study

boolean

C2348568 (UMLS CUI [1])

study subject participation status

Item

13. using another investigational device

boolean

C2348568 (UMLS CUI [1])

comorbidity

Item

14. significant cardiac or pulmonary condition currently under treatment resulting in an asa score >=iii

boolean

C0009488 (UMLS CUI [1])

comorbidity

Item

15. history of, or evidence of, significant brain malformation or significant head injury or clinically apparent cerebral vascular events, or prior brain surgery such as cingulatomy

boolean

C0009488 (UMLS CUI [1])

vagotomy

Item

16. unilateral or bilateral cervical vagotomy

boolean

C0394374 (UMLS CUI [1])

cardiac stimulator

Item

17. demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator

boolean

C0810449 (UMLS CUI [1])

mri

Item

18. likely to require a whole body mri after ncp implantation

boolean

C0024485 (UMLS CUI [1])

diathermy

Item

19. currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation

boolean

C0012002 (UMLS CUI [1])

follow-up

Item

20. plans to relocate or move to a location distant from the study site within one year of enrollment

boolean

C1522577 (UMLS CUI [1])

study subject participation status

Item

21. previously enrolled in this or any other ncp system study -

boolean

C2348568 (UMLS CUI [1])

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Eligibility Major Depressive Disorder NCT00533832