ID

18032

Description

Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.; ODM derived from: https://clinicaltrials.gov/show/NCT00208715

Link

https://clinicaltrials.gov/show/NCT00208715

Keywords

  1. 10/16/16 10/16/16 -
Uploaded on

October 16, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Major Depression NCT00208715

Eligibility Major Depression NCT00208715

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
major depressive disorder
Description

Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1]
C1269683
madrs score ≥ 15 at both screen & baseline.
Description

Montgomery-Asberg Depression Rating Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1]
C4054475
significant fatigue as evidenced by fss ≥4 at both screen & baseline.
Description

Fatigue Significant Evidence of | Fatigue Severity Scale

Data type

boolean

Alias
UMLS CUI [1,1]
C0015672
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0332120
UMLS CUI [2]
C3813323
excessive sleepiness as evidenced by ess ≥ 10 at both screen & baseline.
Description

Hypersomnia Evidence of | Epworth Sleepiness Scale Questionnaire

Data type

boolean

Alias
UMLS CUI [1,1]
C0917799
UMLS CUI [1,2]
C0332120
UMLS CUI [2]
C3541276
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treatment refractory depression
Description

Depressive Disorder, Treatment-Resistant

Data type

boolean

Alias
UMLS CUI [1]
C2063866
serious or unstable medical condition.
Description

medical condition Serious | medical condition Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0443343
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
primary diagnosis of another axis i or ii disorder
Description

Axis I diagnosis (disorder) Principal diagnosis | Axis II diagnosis (disorder) Principal diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0270287
UMLS CUI [1,2]
C0332137
UMLS CUI [2,1]
C0270288
UMLS CUI [2,2]
C0332137
alcohol or substance abuse or dependence within the past 12 months.
Description

Substance Use Disorders | Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580

Similar models

Eligibility Major Depression NCT00208715

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Major Depressive Disorder
Item
major depressive disorder
boolean
C1269683 (UMLS CUI [1])
Montgomery-Asberg Depression Rating Scale Questionnaire
Item
madrs score ≥ 15 at both screen & baseline.
boolean
C4054475 (UMLS CUI [1])
Fatigue Significant Evidence of | Fatigue Severity Scale
Item
significant fatigue as evidenced by fss ≥4 at both screen & baseline.
boolean
C0015672 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0332120 (UMLS CUI [1,3])
C3813323 (UMLS CUI [2])
Hypersomnia Evidence of | Epworth Sleepiness Scale Questionnaire
Item
excessive sleepiness as evidenced by ess ≥ 10 at both screen & baseline.
boolean
C0917799 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C3541276 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Depressive Disorder, Treatment-Resistant
Item
treatment refractory depression
boolean
C2063866 (UMLS CUI [1])
medical condition Serious | medical condition Unstable
Item
serious or unstable medical condition.
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Axis I diagnosis (disorder) Principal diagnosis | Axis II diagnosis (disorder) Principal diagnosis
Item
primary diagnosis of another axis i or ii disorder
boolean
C0270287 (UMLS CUI [1,1])
C0332137 (UMLS CUI [1,2])
C0270288 (UMLS CUI [2,1])
C0332137 (UMLS CUI [2,2])
Substance Use Disorders | Substance Dependence
Item
alcohol or substance abuse or dependence within the past 12 months.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])

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