ID

37419

Description

Ketamine Trial for the Treatment of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02401139

Link

https://clinicaltrials.gov/show/NCT02401139

Keywords

Versions (1)
  1. 7/24/19 7/24/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

July 24, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Unipolar Depression NCT02401139

English

Eligibility Unipolar Depression NCT02401139

1 forms  
Criteria
Description

Criteria

major depressive disorder for at least three months duration
Description

Major Depressive Disorder Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1269683
UMLS CUI [1,2]
C0449238
an inadequate response to at least 2 adequate antidepressants
Description

Antidepressive Agents Quantity | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
madrs ≥ 20
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
patients will be excluded on the basis of:
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
history of psychosis
Description

Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0033975
history of bipolar disorder
Description

Bipolar Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0005586
any unstable medical or neurologic condition
Description

Medical condition Unstable | Neurological condition Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C2359473
UMLS CUI [2,2]
C0443343
any axis i disorder other than mdd judged to be primary presenting problem
Description

Axis I diagnosis Primary problem | Exception Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C3258059
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1269683
planned major changes to psychotropic medication
Description

Psychotropic Drugs Major change Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C3845593
UMLS CUI [1,3]
C1301732
significant risk of suicide
Description

At risk for suicide

Data type

boolean

Alias
UMLS CUI [1]
C0563664
planned or probable use of ect
Description

Electroconvulsive Therapy Planned | Use of Electroconvulsive Therapy Probable

Data type

boolean

Alias
UMLS CUI [1,1]
C0013806
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C1524063
UMLS CUI [2,2]
C0013806
UMLS CUI [2,3]
C0033204
age under 16 years, or 16-17 years without parental consent
Description

Age | Informed Consent Parent Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [2,3]
C0332268
substance abuse or dependence in previous 6 months
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
any history of abuse of ketamine or phencyclidine
Description

Ketamine abuse | Phencyclidine Abuse

Data type

boolean

Alias
UMLS CUI [1]
C3824685
UMLS CUI [2]
C0031391
contraindication to the use of ketamine
Description

Medical contraindication Ketamine

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0022614
planned use of ketamine
Description

Use of Ketamine Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0022614
UMLS CUI [1,3]
C1301732
women of childbearing potential not taking reliable contraception
Description

Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332197
likely non-compliance with trial treatment
Description

Treatment Compliance Unlikely

Data type

boolean

Alias
UMLS CUI [1,1]
C4319828
UMLS CUI [1,2]
C0750558
other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
Description

Condition Impact Completion of clinical trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C4049986
UMLS CUI [1,3]
C2732579
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Similar models

Eligibility Unipolar Depression NCT02401139

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Major Depressive Disorder Duration
Item
major depressive disorder for at least three months duration
boolean
C1269683 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Antidepressive Agents Quantity | Response Inadequate
Item
an inadequate response to at least 2 adequate antidepressants
boolean
C0003289 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
madrs ≥ 20
boolean
C4054475 (UMLS CUI [1])
Exclusion Criteria
Item
patients will be excluded on the basis of:
boolean
C0680251 (UMLS CUI [1])
Psychotic Disorders
Item
history of psychosis
boolean
C0033975 (UMLS CUI [1])
Bipolar Disorder
Item
history of bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Medical condition Unstable | Neurological condition Unstable
Item
any unstable medical or neurologic condition
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C2359473 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Axis I diagnosis Primary problem | Exception Major Depressive Disorder
Item
any axis i disorder other than mdd judged to be primary presenting problem
boolean
C0270287 (UMLS CUI [1,1])
C3258059 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1269683 (UMLS CUI [2,2])
Psychotropic Drugs Major change Planned
Item
planned major changes to psychotropic medication
boolean
C0033978 (UMLS CUI [1,1])
C3845593 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
At risk for suicide
Item
significant risk of suicide
boolean
C0563664 (UMLS CUI [1])
Electroconvulsive Therapy Planned | Use of Electroconvulsive Therapy Probable
Item
planned or probable use of ect
boolean
C0013806 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1524063 (UMLS CUI [2,1])
C0013806 (UMLS CUI [2,2])
C0033204 (UMLS CUI [2,3])
Age | Informed Consent Parent Lacking
Item
age under 16 years, or 16-17 years without parental consent
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
Substance Use Disorders | Substance Dependence
Item
substance abuse or dependence in previous 6 months
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Ketamine abuse | Phencyclidine Abuse
Item
any history of abuse of ketamine or phencyclidine
boolean
C3824685 (UMLS CUI [1])
C0031391 (UMLS CUI [2])
Medical contraindication Ketamine
Item
contraindication to the use of ketamine
boolean
C1301624 (UMLS CUI [1,1])
C0022614 (UMLS CUI [1,2])
Use of Ketamine Planned
Item
planned use of ketamine
boolean
C1524063 (UMLS CUI [1,1])
C0022614 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods Absent
Item
women of childbearing potential not taking reliable contraception
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Treatment Compliance Unlikely
Item
likely non-compliance with trial treatment
boolean
C4319828 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
Condition Impact Completion of clinical trial
Item
other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
boolean
C0348080 (UMLS CUI [1,1])
C4049986 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
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