Bupropion & Cardio Birth Defect (Slone)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: The primary focus of the Slone Epidemiology Center Birth Defects Study (BDS) case-control surveillance is to identify the risks and safety of marketed drugs taken by pregnant women. Infants with any of a wide range of malformations are identified at tertiary care and birth hospitals in four study centers (Boston, Philadelphia, Toronto, San Diego) using approaches that include reviewing lists of discharge diagnoses available in medical records; contacting newborn nursery and/or labor and delivery rooms; reviewing admission/discharge lists; and reviewing clinic and surgical logs. Information gathered on each subject includes name, address, telephone number, diagnostic information, and date of birth. Beginning in 1992, the BDS also included mothers of non-malformed infants: initially these infants were identified exclusively at study hospitals, but in 1998, they expanded their normal newborn capability by obtaining a population-based random sample of newborns in Massachusetts.

About this study

Official title: Bupropion and Cardiac Birth Defects (Slone Epidemiology Center)

Conditions

Depressive Disorder

Being tested

Exposure to any bupropion during the first trimester, Exposure to bupropion alone during the first trimester, Referent group: no exposure to any anti-depressant or anti-smoking drug during pregnancy

Keywords

first trimester, left outflow tract obstruction, Bupropion, cardiovascular malformation, antidepressants, pregnancy, cardiovascular defect, congenital malformation

Medical subject headings

Depressive Disorder, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Exposure to any bupropion during the first trimesterDrug

  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.

• Exposure to bupropion alone during the first trimesterDrug

  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.

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

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Diagnosis of left outflow tract defects

   Measured: Within 6 months of delivery

2. Diagnosis of coarctation of the aorta

   Measured: Within 6 months of delivery

3. Diagnosis of hypoplastic left heart syndrome

   Measured: Within 6 months of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted14 May 2012 (estimated)
2. Study startSep 2011
3. Primary completionAug 2012
4. Study completionAug 2012

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Depressive DisorderStudies of the same condition, open and under way.
• More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.