Bupropion & Cardio Birth Defect (Slone)

CompletedOBSERVATIONAL
Enrollment

1

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Depressive Disorder
Interventions
DRUG

Exposure to any bupropion during the first trimester

"The primary exposure group will be: any exposure to bupropion during the time period from 28 days prior to the last menstrual period through the fourth lunar month. The use of bupropion in combination with other anti-depressants, exposure to SSRI anti-depressants, and exposure to non-SSRI anti-depressants, including tricyclic anti-depressants, during this time period will be explored.~Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves."

DRUG

Exposure to bupropion alone during the first trimester

"The secondary exposure group will be: bupropion exposure alone during the time period from 28 days prior to the last menstrual period through the fourth lunar month.~Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves."

OTHER

Referent group: no exposure to any anti-depressant or anti-smoking drug during pregnancy

"The referent group will be defined as no exposure to any anti-depressant or anti-smoking drug at any time from 28 days prior to the last menstrual period through the end of pregnancy.~Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves."

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01597661 - Bupropion & Cardio Birth Defect (Slone) | Biotech Hunter | Biotech Hunter