Informações:
Falhas:
ID
35692
Descrição
Ketamine for Depression Relapse Prevention Following ECT; ODM derived from: https://clinicaltrials.gov/show/NCT02414932
Link
https://clinicaltrials.gov/show/NCT02414932
Palavras-chave
Versões (1)
- 15/03/2019 15/03/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
15 de março de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Depression NCT02414932
Eligibility Depression NCT02414932
- StudyEvent: Eligibility
Similar models
Eligibility Depression NCT02414932
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
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])
C0038586 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])