ID

15044

Description

A PK/PD Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression; ODM derived from: https://clinicaltrials.gov/show/NCT02286440

Link

https://clinicaltrials.gov/show/NCT02286440

Keywords

Versions (1)
  1. 5/12/16 5/12/16 -
Uploaded on

May 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Depression NCT02286440

English

Eligibility Depression NCT02286440

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02286440
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 13-18, male or female, any race/ethnicity
Description

Age | Racial group | Ethnic group

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0034510
UMLS CUI [3]
C0015031
treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
Description

Indication Pharmacotherapy Part of Comprehensive treatment program

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013216
UMLS CUI [1,3]
C1292711
UMLS CUI [1,4]
C0814471
major depressive episode diagnosis or bipolar disorder based on ksads-pl semi-structured psychiatric interview with a severity criteria-40 or greater on childhood depression rating scale-revised (cdrs-r)
Description

Single major depressive episode | Bipolar Disorder | Severity Criteria Childhood depression Rating scale

Data type

boolean

Alias
UMLS CUI [1]
C0024517
UMLS CUI [2]
C0005586
UMLS CUI [3,1]
C3897634
UMLS CUI [3,2]
C2363919
UMLS CUI [3,3]
C0681889
ability to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inability to speak english
Description

Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
inability or lack of willingness to provide informed consent and assent.
Description

Unable Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
axis i diagnoses: autism spectrum disorder, anorexia nervosa, schizophreniform, and schizophrenia.
Description

Axis I diagnosis | Autism Spectrum Disorders | Anorexia Nervosa | Schizophreniform Disorders | Schizophrenia

Data type

boolean

Alias
UMLS CUI [1]
C0270287
UMLS CUI [2]
C1510586
UMLS CUI [3]
C0003125
UMLS CUI [4]
C0036358
UMLS CUI [5]
C0036341
psychotropic medication change (including dosage) between screening & randomization visits.
Description

Psychotropic Drugs Change of medication | Psychotropic Drugs Medication dose changed | Screening procedure | Randomization

Data type

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0580105
UMLS CUI [2,1]
C0033978
UMLS CUI [2,2]
C1608430
UMLS CUI [3]
C0220908
UMLS CUI [4]
C0034656
patients who meet dsm 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. must have at least early, partial or full, remission x 3 months
Description

Diagnostic and Statistical Manual of Mental Disorders criteria | Substance Use Disorders | Nicotine | Caffeine | Cannabis substance | Disease remission

Data type

boolean

Alias
UMLS CUI [1,1]
C1136324
UMLS CUI [1,2]
C0243161
UMLS CUI [2]
C0038586
UMLS CUI [3]
C0028040
UMLS CUI [4]
C0006644
UMLS CUI [5]
C0678449
UMLS CUI [6]
C0544452
serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
Description

At risk for suicide | Needs Hospitalization

Data type

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2,1]
C0027552
UMLS CUI [2,2]
C0019993
significant unstable medical condition.
Description

medical condition Unstable status

Data type

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C0443343
anticipated inability to attend scheduled study visits.
Description

Unable Visit Study

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C2603343
patients who in the judgment of the investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
Description

Compliance behavior Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
cytochrome (cyp) & serotonin transporter genomic testing within 5 years.
Description

Cytochrome | Serotonin transporter | Genome Testing

Data type

boolean

Alias
UMLS CUI [1]
C0010798
UMLS CUI [2]
C0170657
UMLS CUI [3,1]
C0017428
UMLS CUI [3,2]
C0039593
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Similar models

Eligibility Depression NCT02286440

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Depression NCT02286440
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Racial group | Ethnic group
Item
age 13-18, male or female, any race/ethnicity
boolean
C0001779 (UMLS CUI [1])
C0034510 (UMLS CUI [2])
C0015031 (UMLS CUI [3])
Indication Pharmacotherapy Part of Comprehensive treatment program
Item
treating clinician, patient, and family feel that pharmacotherapy is indicated as part of a comprehensive treatment plan.
boolean
C3146298 (UMLS CUI [1,1])
C0013216 (UMLS CUI [1,2])
C1292711 (UMLS CUI [1,3])
C0814471 (UMLS CUI [1,4])
Single major depressive episode | Bipolar Disorder | Severity Criteria Childhood depression Rating scale
Item
major depressive episode diagnosis or bipolar disorder based on ksads-pl semi-structured psychiatric interview with a severity criteria-40 or greater on childhood depression rating scale-revised (cdrs-r)
boolean
C0024517 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C3897634 (UMLS CUI [3,1])
C2363919 (UMLS CUI [3,2])
C0681889 (UMLS CUI [3,3])
Informed Consent
Item
ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Able to speak English Language
Item
inability to speak english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Unable Informed Consent
Item
inability or lack of willingness to provide informed consent and assent.
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Axis I diagnosis | Autism Spectrum Disorders | Anorexia Nervosa | Schizophreniform Disorders | Schizophrenia
Item
axis i diagnoses: autism spectrum disorder, anorexia nervosa, schizophreniform, and schizophrenia.
boolean
C0270287 (UMLS CUI [1])
C1510586 (UMLS CUI [2])
C0003125 (UMLS CUI [3])
C0036358 (UMLS CUI [4])
C0036341 (UMLS CUI [5])
Psychotropic Drugs Change of medication | Psychotropic Drugs Medication dose changed | Screening procedure | Randomization
Item
psychotropic medication change (including dosage) between screening & randomization visits.
boolean
C0033978 (UMLS CUI [1,1])
C0580105 (UMLS CUI [1,2])
C0033978 (UMLS CUI [2,1])
C1608430 (UMLS CUI [2,2])
C0220908 (UMLS CUI [3])
C0034656 (UMLS CUI [4])
Diagnostic and Statistical Manual of Mental Disorders criteria | Substance Use Disorders | Nicotine | Caffeine | Cannabis substance | Disease remission
Item
patients who meet dsm 5 criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. must have at least early, partial or full, remission x 3 months
boolean
C1136324 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C0038586 (UMLS CUI [2])
C0028040 (UMLS CUI [3])
C0006644 (UMLS CUI [4])
C0678449 (UMLS CUI [5])
C0544452 (UMLS CUI [6])
At risk for suicide | Needs Hospitalization
Item
serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator.
boolean
C0563664 (UMLS CUI [1])
C0027552 (UMLS CUI [2,1])
C0019993 (UMLS CUI [2,2])
medical condition Unstable status
Item
significant unstable medical condition.
boolean
C1699700 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Unable Visit Study
Item
anticipated inability to attend scheduled study visits.
boolean
C1299582 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C2603343 (UMLS CUI [1,3])
Compliance behavior Limited
Item
patients who in the judgment of the investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol.
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Cytochrome | Serotonin transporter | Genome Testing
Item
cytochrome (cyp) & serotonin transporter genomic testing within 5 years.
boolean
C0010798 (UMLS CUI [1])
C0170657 (UMLS CUI [2])
C0017428 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
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