ID

28883

Description

Reclaim Deep Brain Stimulation Clinical Study for Treatment-Resistant Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00837486

Link

https://clinicaltrials.gov/show/NCT00837486

Keywords

  1. 2/10/18 2/10/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 10, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Depression NCT00837486

Eligibility Depression NCT00837486

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00837486
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
consent to participate in screening and study procedures by signing and dating the informed consent form
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
are diagnosed with major depressive disorder (mdd)
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
have tried at least 4 different treatments, for example antidepressant medications, combinations of antidepressant medications, and/or electroconvulsive therapy (ect)
Description

Therapeutic procedure Different Quantity | Antidepressive Agents | Combined Modality Therapy | Electroconvulsive Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1705242
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C0003289
UMLS CUI [3]
C0009429
UMLS CUI [4]
C0013806
screening madrs score ≥ 28
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
have had the current major depressive episode persist for at least 2 years
Description

Major depressive episode persistent Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0024517
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C0449238
females, if of child-bearing potential, must be using an acceptable method of birth control
Description

Childbearing Potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
females: currently pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
currently enrolled in or plan to enroll in any concurrent drug and/or device study that may confound the results of this study
Description

Study Subject Participation Status Interferes with Research results | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
have a neurological condition that may jeopardize the safety or the conduct of the study
Description

Nervous system disorder compromises Clinical Trial Safety | Nervous system disorder compromises Clinical Trial Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0036043
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C0205197
have any medical conditions unsuitable for undergoing dbs surgery
Description

Medical condition Inappropriate Deep Brain Stimulation

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0394162

Similar models

Eligibility Depression NCT00837486

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00837486
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Protocol Compliance | Informed Consent
Item
consent to participate in screening and study procedures by signing and dating the informed consent form
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Major Depressive Disorder
Item
are diagnosed with major depressive disorder (mdd)
boolean
C1269683 (UMLS CUI [1])
Therapeutic procedure Different Quantity | Antidepressive Agents | Combined Modality Therapy | Electroconvulsive Therapy
Item
have tried at least 4 different treatments, for example antidepressant medications, combinations of antidepressant medications, and/or electroconvulsive therapy (ect)
boolean
C0087111 (UMLS CUI [1,1])
C1705242 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0003289 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
C0013806 (UMLS CUI [4])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
screening madrs score ≥ 28
boolean
C4054475 (UMLS CUI [1])
Major depressive episode persistent Duration
Item
have had the current major depressive episode persist for at least 2 years
boolean
C0024517 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods
Item
females, if of child-bearing potential, must be using an acceptable method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
females: currently pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status Interferes with Research results | Investigational New Drugs | Investigational Medical Device
Item
currently enrolled in or plan to enroll in any concurrent drug and/or device study that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Nervous system disorder compromises Clinical Trial Safety | Nervous system disorder compromises Clinical Trial Completion
Item
have a neurological condition that may jeopardize the safety or the conduct of the study
boolean
C0027765 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0027765 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C0205197 (UMLS CUI [2,4])
Medical condition Inappropriate Deep Brain Stimulation
Item
have any medical conditions unsuitable for undergoing dbs surgery
boolean
C3843040 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0394162 (UMLS CUI [1,3])

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