ID

13205

Description

Pivotal Trial (D02) of Vagus Nerve Stimulation (VNS) for Treatment-Resistant Depression (TRD); ODM derived from: https://clinicaltrials.gov/show/NCT00533832

Link

https://clinicaltrials.gov/show/NCT00533832

Keywords

Versions (1)
  1. 1/24/16 1/24/16 -
Uploaded on

January 24, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT00533832

English

Eligibility Major Depressive Disorder NCT00533832

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosed with major depressive episode (mde)
Description

major depressive episode

Data type

boolean

Alias
UMLS CUI [1]
C0024517
2. chronic (>=2 years)or recurrent (>-=4) lifetime mdes
Description

chronic, recurrent mdes

Data type

boolean

Alias
UMLS CUI [1]
C0154409
UMLS CUI [2]
C0520666
3. resistant to >=2 treatments from different categories
Description

treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013203
4. completed >=6 weeks of psychotherapy
Description

psychotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0033968
5. score >=20 on 24-item hamilton rating scale of depression
Description

hamilton rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0451203
6. iq >=70
Description

iq

Data type

boolean

Alias
UMLS CUI [1]
C0456149
7. stable on current antidepressant medication (no more than 5 antidepressant meds) or taking no antidepressant meds for >=4 weeks before visit b1
Description

antidepressants

Data type

boolean

Alias
UMLS CUI [1]
C0003289
8. stable on atypical antipsychotic and anticonvulsant medications as for item #7
Description

antipsychotics, anticonvulsants

Data type

boolean

Alias
UMLS CUI [1]
C0040615
UMLS CUI [2]
C0003286
9. age >=18 amd <=80 years
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
10. male or nonpregnant female adequately protected from conception.
Description

gender, pregnancy, contraception

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0700589
11. able to comply with testing and follow-up visits
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
12. voluntarily signed informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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)
Description

lithium

Data type

boolean

Alias
UMLS CUI [1]
C0005586
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0023870
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0023870
UMLS CUI [4,1]
C0013203
UMLS CUI [4,2]
C0023870
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. atypical depression at study entry or psychotic symptoms in any mde
Description

atypical depression, psychosis

Data type

boolean

Alias
UMLS CUI [1]
C0154437
UMLS CUI [2]
C0033975
2. history of schizophrenia, schizoaffective disorder, or delusional disorders
Description

schizophrenia, schizoaffective disorder, or delusional disorders

Data type

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0036337
UMLS CUI [3]
C0011251
3. rapid cycling bopolar disorder
Description

rapid cycling bipolar disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005586
4. secondary diagnosis of, or signs of, delirium, dementia, amnestic, or other cognitive disorders
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
5. failed 7 or more antidepressant treatments
Description

antidepressants

Data type

boolean

Alias
UMLS CUI [1]
C0003289
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
Description

suicide

Data type

boolean

Alias
UMLS CUI [1]
C0038661
7. alcohol or substance dependence within previous 12 months or abuse within previous 6 mon other than nicotine dependence or abuse
Description

substance abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
8. history of myocardial infarction or cardiac arrest
Description

cardiac disease

Data type

boolean

Alias
UMLS CUI [1]
C0018799
9. other progressive neurological disease, significant central nervous system disease or injury, or cervical fracture that makes implantation difficult
Description

neurological disease

Data type

boolean

Alias
UMLS CUI [1]
C0027765
10. received general anesthesia with 390 days before enrollment.
Description

general anesthesia

Data type

boolean

Alias
UMLS CUI [1]
C0002915
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
Description

medication

Data type

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C2348568
12. enrolled in another investigational study
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
13. using another investigational device
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
14. significant cardiac or pulmonary condition currently under treatment resulting in an asa score >=iii
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
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
Description

comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
16. unilateral or bilateral cervical vagotomy
Description

vagotomy

Data type

boolean

Alias
UMLS CUI [1]
C0394374
17. demand cardiac pacemaker, implantable defibrillator, or other implantable stimulator
Description

cardiac stimulator

Data type

boolean

Alias
UMLS CUI [1]
C0810449
18. likely to require a whole body mri after ncp implantation
Description

mri

Data type

boolean

Alias
UMLS CUI [1]
C0024485
19. currently receiving or likely to receive short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy after implantation
Description

diathermy

Data type

boolean

Alias
UMLS CUI [1]
C0012002
20. plans to relocate or move to a location distant from the study site within one year of enrollment
Description

follow-up

Data type

boolean

Alias
UMLS CUI [1]
C1522577
21. previously enrolled in this or any other ncp system study -
Description

study subject participation status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Major Depressive Disorder NCT00533832

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
iq
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])
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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