7,005
Participants
Start Date
June 30, 2010
Primary Completion Date
December 31, 2010
Study Completion Date
December 31, 2010
3. Exposure to other antidepressants during the first trimester comparison cohort
"Exposure to other antidepressants during first trimester was classified in the original study using pharmacy claims submitted electronically to the Ingenix Research Database to indicate dispensing of other antidepressants. Infants were classified according to maternal exposure to other antidepressants during the first trimester. The first trimester was estimated as the earliest probable conception date through 91 days (13 weeks) following the latest probable conception date (based on delivery diagnosis codes). This study will refine the exposure classifications into infants born to women who were exposed only to one type of an antidepressant (other antidepressant monotherapy), or more than one type of an antidepressant (other antidepressant mono or polytherapy) during the first trimester. A woman was considered exposed if there is at least one dispensing of another antidepressant during the first trimester of pregnancy."
2. Exposure to bupropion outside the first trimester comparison cohort
"Exposure to bupropion outside the first trimester was classified in the original study using pharmacy claims submitted electronically to the Ingenix Research Database to indicate a dispensing of bupropion. The comparison cohort (bupropion exposure outside the first trimester) included women whose bupropion exposure occurred at least one month before the estimated date of conception and women whose bupropion exposure occurred after the first trimester, but before delivery. This study will refine the exposure classifications into infants born to women, who were exposed only to bupropion (bupropion monotherapy), or bupropion and another type of an antidepressant (bupropion mono-or polytherapy) during the period outside the first trimester."
1. Exposure to bupropion during the first trimester
"Exposure to bupropion during the first trimester was classified in the original study using pharmacy claims submitted electronically to the Ingenix Research Database to indicate a dispensing of bupropion. Infants were classified according to maternal exposure to bupropion during the first trimester. The first trimester was estimated as the earliest probable conception date through 91 days (13 weeks) following the latest probable conception date (based on delivery diagnosis codes). This study will refine the exposure classifications into infants born to women, who were exposed only to bupropion (bupropion monotherapy), or bupropion and another type of an antidepressant (bupropion mono-or polytherapy). A woman was considered exposed in the first trimester if there was at least one dispensing of bupropion during the first trimester of pregnancy."
Lead Sponsor
GlaxoSmithKline
INDUSTRY