ID

28835

Beskrivning

Effects of Adding Motivational Interviewing to Antidepressant Treatment for Hispanic Adults With Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00564278

Länk

https://clinicaltrials.gov/show/NCT00564278

Nyckelord

  1. 2018-02-07 2018-02-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 februari 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Depression NCT00564278

Eligibility Depression NCT00564278

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00564278
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
self-identifies as hispanic
Beskrivning

Hispanics

Datatyp

boolean

Alias
UMLS CUI [1]
C0086409
meets diagnostic and statistical manual, 4th edition criteria for major depressive disorder (mdd)
Beskrivning

Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1]
C1269683
score of 16 or higher on hamilton depression scale (ham-d17) at study entry
Beskrivning

Hamilton Depression Rating Scale 17 Item Questionnaire

Datatyp

boolean

Alias
UMLS CUI [1]
C3639712
willing to abstain from other psychotropic medications not included in the texas medication algorithm (tma) for depression, as clinically indicated, for the duration of the study. zolpidem for insomnia will be allowed.
Beskrivning

Avoidance Psychotropic Drugs | Zolpidem allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0033978
UMLS CUI [2,1]
C0078839
UMLS CUI [2,2]
C0683607
fluency in english or spanish
Beskrivning

Able to speak fluently English Language | Able to speak fluently Spanish Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564241
UMLS CUI [2,2]
C0037750
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute suicidality
Beskrivning

Suicidality

Datatyp

boolean

Alias
UMLS CUI [1]
C3166387
history of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic features, or organic brain syndromes
Beskrivning

Schizophrenia | Bipolar Disorder | Schizoaffective Disorder | Depression psychotic feature | Organic brain syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0036337
UMLS CUI [4]
C0743076
UMLS CUI [5]
C0029221
alcohol or other substance abuse or dependence (except nicotine) within 6 months prior to study entry
Beskrivning

Substance Use Disorders | Substance Dependence | Exception Nicotine

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0028040
clinically unstable medical disease, including narrow-angle glaucoma or increased intra-ocular pressure
Beskrivning

Disease Unstable | Angle Closure Glaucoma | Raised intraocular pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0017605
UMLS CUI [3]
C0234708
systemic blood pressure of 140/90 mm hg or less
Beskrivning

Systemic arterial pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C1272641
liver function test values two times above the normal level
Beskrivning

Increased liver function tests

Datatyp

boolean

Alias
UMLS CUI [1]
C0877359
pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
sexually active women not using an effective method of birth control
Beskrivning

Gender Sexually active | Contraceptive methods Lacking

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0332268
current or past history of seizure disorder (except febrile seizure in childhood)
Beskrivning

Epilepsy | Exception Febrile Convulsions Childhood

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0009952
UMLS CUI [2,3]
C0231335
receiving effective medication for mdd
Beskrivning

Pharmaceutical Preparations Effective Major Depressive Disorder

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1280519
UMLS CUI [1,3]
C1269683
unable to tolerate or unwilling to accept drug-free period of varying length: 1 week for benzodiazepines taken as needed; 2 weeks for buspirone, lithium, anticonvulsants, stimulants, barbiturates, opiates, and regular-use benzodiazepines (except clonazepam); and 5 weeks for clonazepam
Beskrivning

Period Pharmaceutical Preparations Discontinuation Unable | Period Pharmaceutical Preparations Discontinuation Unwilling | Benzodiazepines | Buspirone | Lithium | Anticonvulsants | Stimulant | Barbiturates | Opiates | Benzodiazepines Use of Regular | Clonazepam

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1948053
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C1444662
UMLS CUI [1,4]
C1299582
UMLS CUI [2,1]
C1948053
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C1444662
UMLS CUI [2,4]
C0558080
UMLS CUI [3]
C0005064
UMLS CUI [4]
C0006462
UMLS CUI [5]
C0023870
UMLS CUI [6]
C0003286
UMLS CUI [7]
C0304402
UMLS CUI [8]
C0004745
UMLS CUI [9]
C0376196
UMLS CUI [10,1]
C0005064
UMLS CUI [10,2]
C1524063
UMLS CUI [10,3]
C0205272
UMLS CUI [11]
C0009011
received electroconvulsive therapy (ect) within 3 months prior to study entry
Beskrivning

Electroconvulsive Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0013806
parkinson's disease, dementia of any type, or cognitive impairment
Beskrivning

Parkinson Disease | Dementia Type Any | Impaired cognition

Datatyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0497327
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1552551
UMLS CUI [3]
C0338656

Similar models

Eligibility Depression NCT00564278

  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT00564278
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Hispanics
Item
self-identifies as hispanic
boolean
C0086409 (UMLS CUI [1])
Major Depressive Disorder
Item
meets diagnostic and statistical manual, 4th edition criteria for major depressive disorder (mdd)
boolean
C1269683 (UMLS CUI [1])
Hamilton Depression Rating Scale 17 Item Questionnaire
Item
score of 16 or higher on hamilton depression scale (ham-d17) at study entry
boolean
C3639712 (UMLS CUI [1])
Avoidance Psychotropic Drugs | Zolpidem allowed
Item
willing to abstain from other psychotropic medications not included in the texas medication algorithm (tma) for depression, as clinically indicated, for the duration of the study. zolpidem for insomnia will be allowed.
boolean
C0870186 (UMLS CUI [1,1])
C0033978 (UMLS CUI [1,2])
C0078839 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
Able to speak fluently English Language | Able to speak fluently Spanish Language
Item
fluency in english or spanish
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564241 (UMLS CUI [2,1])
C0037750 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Suicidality
Item
acute suicidality
boolean
C3166387 (UMLS CUI [1])
Schizophrenia | Bipolar Disorder | Schizoaffective Disorder | Depression psychotic feature | Organic brain syndrome
Item
history of schizophrenia, bipolar affective disorder, schizoaffective disorder, depression with psychotic features, or organic brain syndromes
boolean
C0036341 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0036337 (UMLS CUI [3])
C0743076 (UMLS CUI [4])
C0029221 (UMLS CUI [5])
Substance Use Disorders | Substance Dependence | Exception Nicotine
Item
alcohol or other substance abuse or dependence (except nicotine) within 6 months prior to study entry
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0028040 (UMLS CUI [3,2])
Disease Unstable | Angle Closure Glaucoma | Raised intraocular pressure
Item
clinically unstable medical disease, including narrow-angle glaucoma or increased intra-ocular pressure
boolean
C0012634 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0017605 (UMLS CUI [2])
C0234708 (UMLS CUI [3])
Systemic arterial pressure
Item
systemic blood pressure of 140/90 mm hg or less
boolean
C1272641 (UMLS CUI [1])
Increased liver function tests
Item
liver function test values two times above the normal level
boolean
C0877359 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Gender Sexually active | Contraceptive methods Lacking
Item
sexually active women not using an effective method of birth control
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Epilepsy | Exception Febrile Convulsions Childhood
Item
current or past history of seizure disorder (except febrile seizure in childhood)
boolean
C0014544 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0009952 (UMLS CUI [2,2])
C0231335 (UMLS CUI [2,3])
Pharmaceutical Preparations Effective Major Depressive Disorder
Item
receiving effective medication for mdd
boolean
C0013227 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
C1269683 (UMLS CUI [1,3])
Period Pharmaceutical Preparations Discontinuation Unable | Period Pharmaceutical Preparations Discontinuation Unwilling | Benzodiazepines | Buspirone | Lithium | Anticonvulsants | Stimulant | Barbiturates | Opiates | Benzodiazepines Use of Regular | Clonazepam
Item
unable to tolerate or unwilling to accept drug-free period of varying length: 1 week for benzodiazepines taken as needed; 2 weeks for buspirone, lithium, anticonvulsants, stimulants, barbiturates, opiates, and regular-use benzodiazepines (except clonazepam); and 5 weeks for clonazepam
boolean
C1948053 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1299582 (UMLS CUI [1,4])
C1948053 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C0005064 (UMLS CUI [3])
C0006462 (UMLS CUI [4])
C0023870 (UMLS CUI [5])
C0003286 (UMLS CUI [6])
C0304402 (UMLS CUI [7])
C0004745 (UMLS CUI [8])
C0376196 (UMLS CUI [9])
C0005064 (UMLS CUI [10,1])
C1524063 (UMLS CUI [10,2])
C0205272 (UMLS CUI [10,3])
C0009011 (UMLS CUI [11])
Electroconvulsive Therapy
Item
received electroconvulsive therapy (ect) within 3 months prior to study entry
boolean
C0013806 (UMLS CUI [1])
Parkinson Disease | Dementia Type Any | Impaired cognition
Item
parkinson's disease, dementia of any type, or cognitive impairment
boolean
C0030567 (UMLS CUI [1])
C0497327 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0338656 (UMLS CUI [3])

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