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])
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])
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])
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])
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])
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])
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])