Information:
Fel:
ID
43818
Beskrivning
Major Depressive Disorder With Mixed Features; ODM derived from: https://clinicaltrials.gov/show/NCT01423240
Länk
https://clinicaltrials.gov/show/NCT01423240
Nyckelord
Versioner (2)
- 2016-03-13 2016-03-13 -
- 2021-09-20 2021-09-20 -
Uppladdad den
20 september 2021
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Major Depressive Disorder NCT01423240
Eligibility Major Depressive Disorder NCT01423240
- StudyEvent: Eligibility
Similar models
Eligibility Major Depressive Disorder NCT01423240
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
informed consent
Item
subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the investigator.
boolean
C0021430 (UMLS CUI [1])
age; dsm-iv
Item
subject is 18 to 75 years of age, inclusive. subject has mdd (diagnosed by dsm-iv-tr, and confirmed by the structured clinical interview for dsm-iv disorders - clinical trial version [scid-ct]).
boolean
C0001779 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
C0220952 (UMLS CUI [2])
major depressive episode; dsm-iv
Item
subject is currently experiencing a major depressive episode (diagnosed by dsm-iv-tr; at least 2 weeks in duration) and two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the scid-ct modified for study d1050305):
boolean
C0024517 (UMLS CUI [1])
C0220952 (UMLS CUI [2])
C0220952 (UMLS CUI [2])
expansive mood
Item
elevated, expansive mood
boolean
C0233492 (UMLS CUI [1])
inflated Self Esteem
Item
inflated self-esteem or grandiosity
boolean
C0424121 (UMLS CUI [1])
talkative
Item
more talkative than usual or pressure to keep talking
boolean
C0241331 (UMLS CUI [1])
Racing thoughts
Item
flight of ideas or subjective experience that thoughts are racing
boolean
C0554978 (UMLS CUI [1])
Socializing; sexual activity
Item
increase in energy or goal-directed activity (either socially, at work or school, or sexually)
boolean
C2371613 (UMLS CUI [1])
C0036864 (UMLS CUI [2])
C0036864 (UMLS CUI [2])
activity Pain
Item
increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
boolean
C0026606 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,2])
insomnia; Montgomery-Åsberg depression rating scale
Item
decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia) subject has a rater-administered montgomery-asberg depression rating scale (madrs) total score of ≥ 26 at screening and both a rater-administered and self-rated (administered by computer) madrs total score ≥ 26 at baseline.
boolean
C0917801 (UMLS CUI [1])
C2960593 (UMLS CUI [2])
C2960593 (UMLS CUI [2])
suicidal ideation; Axis I diagnosis
Item
subject has axis i or axis ii diagnosis other than mdd that has been the primary focus of treatment within the 3 months prior to screening subject answers "yes" to "suicidal ideation" item 4 or 5 on the c-ssrs (at time of evaluation) at screening or baseline visit.
boolean
C0424000 (UMLS CUI [1])
C0270287 (UMLS CUI [2])
C0270287 (UMLS CUI [2])
bipolar; maniac
Item
subject has attempted suicide within the past 3 months. subject has a lifetime history of any bipolar i manic or mixed manic episode. subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the investigator.
boolean
C0005586 (UMLS CUI [1])
C0338831 (UMLS CUI [2])
C0338831 (UMLS CUI [2])