ID

35692

Beschrijving

Ketamine for Depression Relapse Prevention Following ECT; ODM derived from: https://clinicaltrials.gov/show/NCT02414932

Link

https://clinicaltrials.gov/show/NCT02414932

Trefwoorden

Versies (1)
  1. 15-03-19 15-03-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

15 maart 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Depression NCT02414932

Engels

Eligibility Depression NCT02414932

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02414932
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥18 years with unipolar major depressive disorder (dsm-iv)
Beschrijving

Age | Major Depressive Disorder Unipolar

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1269683
UMLS CUI [2,2]
C0443340
24-item hamilton rating scale for depression (hrsd-24) score of ≥21
Beschrijving

Hamilton Depression Rating Scale-24 Item Clinical Classification

Datatype

boolean

Alias
UMLS CUI [1]
C4330187
referred for ect
Beschrijving

Referral for Electroconvulsive Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C2585524
UMLS CUI [1,2]
C0013806
for the randomised phase 2, patients must have
Beschrijving

Randomization Trial Phase

Datatype

boolean

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C1710475
received a substantial course of ect in phase 1 (i.e. at least five sessions)
Beschrijving

Course Electroconvulsive Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750729
UMLS CUI [1,2]
C0013806
achieved at least response criteria (i.e. ≥60% decrease from baseline hrsd-24 score and score ≤16 on two consecutive weekly ratings)
Beschrijving

Response Criteria Fulfill | Hamilton Depression Rating Scale-24 Item Clinical Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C1704632
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1550543
UMLS CUI [2]
C4330187
have a nominated adult who can stay with them for 24-hours on out-patient treatment days
Beschrijving

Adult Caregiver | Outpatient Treatment

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0085537
UMLS CUI [2,1]
C0029921
UMLS CUI [2,2]
C0087111
mini-mental state examination (mmse) score of ≥24
Beschrijving

Mini-mental state examination

Datatype

boolean

Alias
UMLS CUI [1]
C0451306
able to provide informed consent
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any condition rendering patient medically unfit for ect; general anaesthesia, ketamine or midazolam - assessed by physical examination, routine haematology and biochemistry investigations prior to enrolment in phase i (routine care)
Beschrijving

Patients Medically unfit Electroconvulsive Therapy | General Anesthesia | Ketamine | Midazolam | Physical Examination | Hematology procedure | Biochemistry test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0013806
UMLS CUI [2]
C0002915
UMLS CUI [3]
C0022614
UMLS CUI [4]
C0026056
UMLS CUI [5]
C0031809
UMLS CUI [6]
C0200627
UMLS CUI [7]
C1655775
active suicidal intention
Beschrijving

Suicidal intention

Datatype

boolean

Alias
UMLS CUI [1]
C2363876
dementia, intellectual disability, or mmse <24
Beschrijving

Dementia | Intellectual Disability | Mini-mental state examination

Datatype

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C3714756
UMLS CUI [3]
C0451306
lifetime history of bipolar affective disorder
Beschrijving

Bipolar Disorder Lifetime

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005586
UMLS CUI [1,2]
C4071830
current history of post-traumatic stress disorder
Beschrijving

Post-Traumatic Stress Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0038436
other axis i diagnosis (dsm-iv)
Beschrijving

Axis I diagnosis

Datatype

boolean

Alias
UMLS CUI [1]
C0270287
ect in the six months prior to recruitment
Beschrijving

Electroconvulsive Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C0013806
alcohol dependence or substance misuse in the six months prior to recruitment
Beschrijving

Alcoholic Intoxication, Chronic | Substance Use Disorders

Datatype

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0038586
pregnancy or breast-feeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
residing in a nursing home
Beschrijving

Nursing home resident

Datatype

boolean

Alias
UMLS CUI [1]
C0682287
prisoner
Beschrijving

Prisoners

Datatype

boolean

Alias
UMLS CUI [1]
C0033167
diagnosis of terminal illness
Beschrijving

Terminal illness

Datatype

boolean

Alias
UMLS CUI [1]
C0679247
inability or refusal to provide valid informed consent
Beschrijving

Informed Consent Unable | Informed Consent Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
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Similar models

Eligibility Depression NCT02414932

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02414932
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Major Depressive Disorder Unipolar
Item
patients ≥18 years with unipolar major depressive disorder (dsm-iv)
boolean
C0001779 (UMLS CUI [1])
C1269683 (UMLS CUI [2,1])
C0443340 (UMLS CUI [2,2])
Hamilton Depression Rating Scale-24 Item Clinical Classification
Item
24-item hamilton rating scale for depression (hrsd-24) score of ≥21
boolean
C4330187 (UMLS CUI [1])
Referral for Electroconvulsive Therapy
Item
referred for ect
boolean
C2585524 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
Randomization Trial Phase
Item
for the randomised phase 2, patients must have
boolean
C0034656 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Course Electroconvulsive Therapy
Item
received a substantial course of ect in phase 1 (i.e. at least five sessions)
boolean
C0750729 (UMLS CUI [1,1])
C0013806 (UMLS CUI [1,2])
Response Criteria Fulfill | Hamilton Depression Rating Scale-24 Item Clinical Classification
Item
achieved at least response criteria (i.e. ≥60% decrease from baseline hrsd-24 score and score ≤16 on two consecutive weekly ratings)
boolean
C1704632 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C4330187 (UMLS CUI [2])
Adult Caregiver | Outpatient Treatment
Item
have a nominated adult who can stay with them for 24-hours on out-patient treatment days
boolean
C0001675 (UMLS CUI [1,1])
C0085537 (UMLS CUI [1,2])
C0029921 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
Mini-mental state examination
Item
mini-mental state examination (mmse) score of ≥24
boolean
C0451306 (UMLS CUI [1])
Informed Consent
Item
able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Patients Medically unfit Electroconvulsive Therapy | General Anesthesia | Ketamine | Midazolam | Physical Examination | Hematology procedure | Biochemistry test
Item
any condition rendering patient medically unfit for ect; general anaesthesia, ketamine or midazolam - assessed by physical examination, routine haematology and biochemistry investigations prior to enrolment in phase i (routine care)
boolean
C0030705 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0013806 (UMLS CUI [1,3])
C0002915 (UMLS CUI [2])
C0022614 (UMLS CUI [3])
C0026056 (UMLS CUI [4])
C0031809 (UMLS CUI [5])
C0200627 (UMLS CUI [6])
C1655775 (UMLS CUI [7])
Suicidal intention
Item
active suicidal intention
boolean
C2363876 (UMLS CUI [1])
Dementia | Intellectual Disability | Mini-mental state examination
Item
dementia, intellectual disability, or mmse <24
boolean
C0497327 (UMLS CUI [1])
C3714756 (UMLS CUI [2])
C0451306 (UMLS CUI [3])
Bipolar Disorder Lifetime
Item
lifetime history of bipolar affective disorder
boolean
C0005586 (UMLS CUI [1,1])
C4071830 (UMLS CUI [1,2])
Post-Traumatic Stress Disorder
Item
current history of post-traumatic stress disorder
boolean
C0038436 (UMLS CUI [1])
Axis I diagnosis
Item
other axis i diagnosis (dsm-iv)
boolean
C0270287 (UMLS CUI [1])
Electroconvulsive Therapy
Item
ect in the six months prior to recruitment
boolean
C0013806 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
alcohol dependence or substance misuse in the six months prior to recruitment
boolean
C0001973 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Nursing home resident
Item
residing in a nursing home
boolean
C0682287 (UMLS CUI [1])
Prisoners
Item
prisoner
boolean
C0033167 (UMLS CUI [1])
Terminal illness
Item
diagnosis of terminal illness
boolean
C0679247 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Refused
Item
inability or refusal to provide valid informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
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