ID

13689

Beskrivning

Transcranial Magnetic Stimulation in Major Depression With EEG and Near Infrared Spectroscopy (NIRS) Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT01192685

Länk

https://clinicaltrials.gov/show/NCT01192685

Nyckelord

Versioner (1)
  1. 2016-02-28 2016-02-28 -
Uppladdad den

28 februari 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Depression NCT01192685

Engelsk

Eligibility Depression NCT01192685

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01192685
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. depressive disorder diagnostic statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr).
Beskrivning

depressive disorder; dsm-iv

Datatyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0220952
2. madras score of 26 or above and history of depression, as defined by meeting dsm-iv criteria for major depression, dysthymic disorder, or substance-induced mood disorder.
Beskrivning

major depression; dysthymic disorder; substance-induced mood disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0013415
UMLS CUI [3]
C3267135
3. male or female aged 18 to 65.
Beskrivning

gender; age

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
4. females who are not pregnant or nursing.
Beskrivning

Contraception status

Datatyp

boolean

Alias
UMLS CUI [1]
C0420837
5. individuals able to provide informed written consent and are able to comply with study procedures.
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
6. subjects who have received or are receiving anti-depressant medication.
Beskrivning

antidepressant agents

Datatyp

boolean

Alias
UMLS CUI [1]
C0003289
7. patients who are depressed as assessed by the above criteria and have not had optimum response to their antidepressant medication in their current episode.
Beskrivning

depressive episode

Datatyp

boolean

Alias
UMLS CUI [1]
C0349217
exclusion criteria list
Beskrivning

exclusion criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
1. any axis i diagnosis that, in the opinion of the investigators, may interfere with the course of the trial.
Beskrivning

Axis I diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0270287
2. any current diagnoses of alcohol abuse or dependence.
Beskrivning

alcohol abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0085762
3. any current substance use disorder.
Beskrivning

substance use disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
4. medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with tms.
Beskrivning

Compliance behavior Limited Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
5. currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, inh, meperidine, lidocaine, and clozapine.
Beskrivning

tricyclic antidepressants; lidocaine; clozapine

Datatyp

boolean

Alias
UMLS CUI [1]
C0003290
UMLS CUI [2]
C0023660
UMLS CUI [3]
C0009079
6. subjects who have implanted metallic devices or non-removable metallic objects in or around the head that can be magnetized, however metal fillings, braces, and dental implants are acceptable.
Beskrivning

Implants metal; dental implants

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0025552
UMLS CUI [2]
C0011373
7. subjects who have implanted devices that emit physiological signals including cardioverter defibrillators (icds), and vagus nerve stimulators.
Beskrivning

cardioverter defibrillators; vagus nerve stimulators

Datatyp

boolean

Alias
UMLS CUI [1]
C0810516
UMLS CUI [2]
C1458051
8. subjects who have received any investigational drug during the prior 30 days.
Beskrivning

study drug

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0008972
9. clinically significant abnormal lab values as assesses by the investigator.
Beskrivning

laboratory measurement abnormal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681902
UMLS CUI [1,2]
C0205161
10. risk for suicidal behavior based on clinician assessment and a score of greater than 5 on the suicidal thought item of the madrs or a score of 4 on the suicide item of the hamilton depression rating scale.
Beskrivning

suicidal behavior; hamilton depression rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1760428
UMLS CUI [2]
C0451203
11. subjects who have had a serious suicide attempt in the past year as assessed by the investigator.
Beskrivning

suicide attempt

Datatyp

boolean

Alias
UMLS CUI [1]
C0038663
12. current other somatic antidepressant therapy, i.e. vagus nerve stimulation, electroconvulsive therapy, or phototherapy.
Beskrivning

Antidepressant therapy somatic; electroconvulsive therapy; phototherapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096649
UMLS CUI [1,2]
C2986476
UMLS CUI [2]
C0013806
UMLS CUI [3]
C0031765
13. started psychotherapy in the past 30 days.
Beskrivning

psychotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0033968
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Similar models

Eligibility Depression NCT01192685

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT01192685
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
depressive disorder; dsm-iv
Item
1. depressive disorder diagnostic statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr).
boolean
C0011581 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
major depression; dysthymic disorder; substance-induced mood disorder
Item
2. madras score of 26 or above and history of depression, as defined by meeting dsm-iv criteria for major depression, dysthymic disorder, or substance-induced mood disorder.
boolean
C1269683 (UMLS CUI [1])
C0013415 (UMLS CUI [2])
C3267135 (UMLS CUI [3])
gender; age
Item
3. male or female aged 18 to 65.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Contraception status
Item
4. females who are not pregnant or nursing.
boolean
C0420837 (UMLS CUI [1])
informed consent
Item
5. individuals able to provide informed written consent and are able to comply with study procedures.
boolean
C0021430 (UMLS CUI [1])
antidepressant agents
Item
6. subjects who have received or are receiving anti-depressant medication.
boolean
C0003289 (UMLS CUI [1])
depressive episode
Item
7. patients who are depressed as assessed by the above criteria and have not had optimum response to their antidepressant medication in their current episode.
boolean
C0349217 (UMLS CUI [1])
exclusion criteria
Item
exclusion criteria list
boolean
C0680251 (UMLS CUI [1])
Axis I diagnosis
Item
1. any axis i diagnosis that, in the opinion of the investigators, may interfere with the course of the trial.
boolean
C0270287 (UMLS CUI [1])
alcohol abuse
Item
2. any current diagnoses of alcohol abuse or dependence.
boolean
C0085762 (UMLS CUI [1])
substance use disorder
Item
3. any current substance use disorder.
boolean
C0038586 (UMLS CUI [1])
Compliance behavior Limited Comorbidity
Item
4. medical or neurological illness that in the investigators judgment would make study compliance difficult or would be a contraindication for use with tms.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
tricyclic antidepressants; lidocaine; clozapine
Item
5. currently receiving any medication that markedly increases the risks for seizures, for example: tricyclic antidepressants, inh, meperidine, lidocaine, and clozapine.
boolean
C0003290 (UMLS CUI [1])
C0023660 (UMLS CUI [2])
C0009079 (UMLS CUI [3])
Implants metal; dental implants
Item
6. subjects who have implanted metallic devices or non-removable metallic objects in or around the head that can be magnetized, however metal fillings, braces, and dental implants are acceptable.
boolean
C0021102 (UMLS CUI [1,1])
C0025552 (UMLS CUI [1,2])
C0011373 (UMLS CUI [2])
cardioverter defibrillators; vagus nerve stimulators
Item
7. subjects who have implanted devices that emit physiological signals including cardioverter defibrillators (icds), and vagus nerve stimulators.
boolean
C0810516 (UMLS CUI [1])
C1458051 (UMLS CUI [2])
study drug
Item
8. subjects who have received any investigational drug during the prior 30 days.
boolean
C0013227 (UMLS CUI [1,1])
C0008972 (UMLS CUI [1,2])
laboratory measurement abnormal
Item
9. clinically significant abnormal lab values as assesses by the investigator.
boolean
C0681902 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
suicidal behavior; hamilton depression rating scale
Item
10. risk for suicidal behavior based on clinician assessment and a score of greater than 5 on the suicidal thought item of the madrs or a score of 4 on the suicide item of the hamilton depression rating scale.
boolean
C1760428 (UMLS CUI [1])
C0451203 (UMLS CUI [2])
suicide attempt
Item
11. subjects who have had a serious suicide attempt in the past year as assessed by the investigator.
boolean
C0038663 (UMLS CUI [1])
Antidepressant therapy somatic; electroconvulsive therapy; phototherapy
Item
12. current other somatic antidepressant therapy, i.e. vagus nerve stimulation, electroconvulsive therapy, or phototherapy.
boolean
C1096649 (UMLS CUI [1,1])
C2986476 (UMLS CUI [1,2])
C0013806 (UMLS CUI [2])
C0031765 (UMLS CUI [3])
psychotherapy
Item
13. started psychotherapy in the past 30 days.
boolean
C0033968 (UMLS CUI [1])
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