DepressionNCT00279370
Antidepressant Use During Pregnancy
An observational study of Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine the safety of antidepressant use during pregnancy for both the mother and the child. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 283 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1999to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with or without active depression and with or without SSRI use in pregnancy
Who may be able to join
- Less than 24 weeks pregnant at the time of study entry
- As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy
Who cannot join
- History of or current psychosis, bipolar disorder, or schizoaffective disorder
- Current substance use disorder
- Any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes)
- Has not attended at least two prenatal visits at the 20-week intake point
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Behavioral HealthCARE Program
Pittsburgh, Pennsylvania, 15213
About this study
This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
Read the detailed description
Symptoms of major depressive disorder (MDD) include persistent sad mood, feelings of hopelessness or guilt, decreased energy, irritability, and more. If untreated, MDD can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. MDD occurs most commonly in females between the ages of 25 and 44. This puts women of childbearing age at a particularly high risk for developing the disorder. However, very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby. This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
Participants in this observational study will not receive medication or treatment of any kind. Pregnant woman who are already taking medication for depression will be recruited, in addition to pregnant women who are not taking any medication. The participants will first undergo interviews to establish their psychiatric diagnoses. Subsequent interviews will be held to monitor levels of depressive symptoms, exposure to other substances that could potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during pregnancy. Participants will report to the study site for these evaluations at Weeks 20, 30, and 36 of pregnancy. From Week 36 to Week 40, interviews will be conducted over the phone.
At birth, cord blood will be collected and the infant's cries will be recorded. The infant's development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. Mothers who take selective serotonin reuptake inhibitors (SSRIs) and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infant's blood. In addition, digital photographs of the infant's face, profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum. Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics. Mother-child interactions will be videotaped at all postpartum assessments.
- Conditions
- Depression
- Keywords
- SSRI Exposure, Pregnancy, Infant Development
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
SIGH-ADS
Measured: 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum
Bayley Scales of Infant Development
Measured: 12, 28, 52, and 104 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startSep 1999
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Katherine Wisner, University of Pittsburgh
- Investigators
- Katherine L. Wisner, MD MS, Principal investigator, University of Pittsburgh, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279370
- Sponsor's protocol ID
- R01MH060335
- Other IDs
- R01MH060335, DSIR AT-SO
- Status last verified
- Sep 2013
- First submitted
- 17 Jan 2006
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gollan JK, Yang A, Ciolino JD, Sit D, Wisner KL. Postpartum anhedonia: Emergent patterns in bipolar and unipolar depression. Psychiatry Res. 2021 Dec;306:114274. doi: 10.1016/j.psychres.2021.114274. Epub 2021 Nov 9.
PubMed 34837882Wisner KL, Sit D, O'Shea K, Bogen DL, Clark CT, Pinheiro E, Yang A, Ciolino JD. Bipolar disorder and psychotropic medication: Impact on pregnancy and neonatal outcomes. J Affect Disord. 2019 Jan 15;243:220-225. doi: 10.1016/j.jad.2018.09.045. Epub 2018 Sep 18.
PubMed 30248632Yang A, Ciolino JD, Pinheiro E, Rasmussen-Torvik LJ, Sit DKY, Wisner KL. Neonatal Discontinuation Syndrome in Serotonergic Antidepressant-Exposed Neonates. J Clin Psychiatry. 2017 May;78(5):605-611. doi: 10.4088/JCP.16m11044.
PubMed 28570796Kim DR, Pinheiro E, Luther JF, Eng HF, Dills JL, Wisniewski SR, Wisner KL. Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res. 2016 Feb;73:79-85. doi: 10.1016/j.jpsychires.2015.11.005. Epub 2015 Nov 19.
PubMed 26692255Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Dills JL, Sit DK, Hanusa BH, Wisner KL. Impact of prenatal exposure to serotonin reuptake inhibitors or maternal major depressive disorder on infant developmental outcomes. J Clin Psychiatry. 2014 Oct;75(10):1088-95. doi: 10.4088/JCP.13m08902.
PubMed 25373117Sit D, Perel JM, Wisniewski SR, Helsel JC, Luther JF, Wisner KL. Mother-infant antidepressant concentrations, maternal depression, and perinatal events. J Clin Psychiatry. 2011 Jul;72(7):994-1001. doi: 10.4088/JCP.10m06461.
PubMed 21824458Sit D, Perel JM, Luther JF, Wisniewski SR, Helsel JC, Wisner KL. Disposition of chiral and racemic fluoxetine and norfluoxetine across childbearing. J Clin Psychopharmacol. 2010 Aug;30(4):381-6. doi: 10.1097/JCP.0b013e3181e7be23.
PubMed 20631556Wisner KL, Sit DK, Hanusa BH, Moses-Kolko EL, Bogen DL, Hunker DF, Perel JM, Jones-Ivy S, Bodnar LM, Singer LT. Major depression and antidepressant treatment: impact on pregnancy and neonatal outcomes. Am J Psychiatry. 2009 May;166(5):557-66. doi: 10.1176/appi.ajp.2008.08081170. Epub 2009 Mar 16.
PubMed 19289451Sit DK, Perel JM, Helsel JC, Wisner KL. Changes in antidepressant metabolism and dosing across pregnancy and early postpartum. J Clin Psychiatry. 2008 Apr;69(4):652-8. doi: 10.4088/jcp.v69n0419.
PubMed 18426260
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Use During Pregnancy
- ClinicalTrials.gov ID
- NCT00279370
- Acronym / sponsor ID
- R01MH060335
- Conditions
- Depression
- Keywords
- SSRI Exposure, Pregnancy, Infant Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 1999
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
Detailed description
Symptoms of major depressive disorder (MDD) include persistent sad mood, feelings of hopelessness or guilt, decreased energy, irritability, and more. If untreated, MDD can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. MDD occurs most commonly in females between the ages of 25 and 44. This puts women of childbearing age at a particularly high risk for developing the disorder. However, very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby. This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
Participants in this observational study will not receive medication or treatment of any kind. Pregnant woman who are already taking medication for depression will be recruited, in addition to pregnant women who are not taking any medication. The participants will first undergo interviews to establish their psychiatric diagnoses. Subsequent interviews will be held to monitor levels of depressive symptoms, exposure to other substances that could potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during pregnancy. Participants will report to the study site for these evaluations at Weeks 20, 30, and 36 of pregnancy. From Week 36 to Week 40, interviews will be conducted over the phone.
At birth, cord blood will be collected and the infant's cries will be recorded. The infant's development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. Mothers who take selective serotonin reuptake inhibitors (SSRIs) and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infant's blood. In addition, digital photographs of the infant's face, profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum. Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics. Mother-child interactions will be videotaped at all postpartum assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with or without active depression and with or without SSRI use in pregnancy
Key inclusion criteria (2 listed)
- Less than 24 weeks pregnant at the time of study entry
- As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy
Key exclusion criteria (4 listed)
- History of or current psychosis, bipolar disorder, or schizoaffective disorder
- Current substance use disorder
- Any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes)
- Has not attended at least two prenatal visits at the 20-week intake point
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SIGH-ADS
Time frame: 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum
Bayley Scales of Infant Development
Time frame: 12, 28, 52, and 104 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2013.
- Derived from this study: PubMed 34837882Gollan JK, Yang A, Ciolino JD, Sit D, Wisner KL. Postpartum anhedonia: Emergent patterns in bipolar and unipolar depression. Psychiatry Res. 2021 Dec;306:114274. doi: 10.1016/j.psychres.2021.114274. Epub 2021 Nov 9.
- Derived from this study: PubMed 30248632Wisner KL, Sit D, O'Shea K, Bogen DL, Clark CT, Pinheiro E, Yang A, Ciolino JD. Bipolar disorder and psychotropic medication: Impact on pregnancy and neonatal outcomes. J Affect Disord. 2019 Jan 15;243:220-225. doi: 10.1016/j.jad.2018.09.045. Epub 2018 Sep 18.
- Derived from this study: PubMed 28570796Yang A, Ciolino JD, Pinheiro E, Rasmussen-Torvik LJ, Sit DKY, Wisner KL. Neonatal Discontinuation Syndrome in Serotonergic Antidepressant-Exposed Neonates. J Clin Psychiatry. 2017 May;78(5):605-611. doi: 10.4088/JCP.16m11044.
- Derived from this study: PubMed 26692255Kim DR, Pinheiro E, Luther JF, Eng HF, Dills JL, Wisniewski SR, Wisner KL. Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res. 2016 Feb;73:79-85. doi: 10.1016/j.jpsychires.2015.11.005. Epub 2015 Nov 19.
- Derived from this study: PubMed 25373117Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Dills JL, Sit DK, Hanusa BH, Wisner KL. Impact of prenatal exposure to serotonin reuptake inhibitors or maternal major depressive disorder on infant developmental outcomes. J Clin Psychiatry. 2014 Oct;75(10):1088-95. doi: 10.4088/JCP.13m08902.
- Derived from this study: PubMed 21824458Sit D, Perel JM, Wisniewski SR, Helsel JC, Luther JF, Wisner KL. Mother-infant antidepressant concentrations, maternal depression, and perinatal events. J Clin Psychiatry. 2011 Jul;72(7):994-1001. doi: 10.4088/JCP.10m06461.
- Derived from this study: PubMed 20631556Sit D, Perel JM, Luther JF, Wisniewski SR, Helsel JC, Wisner KL. Disposition of chiral and racemic fluoxetine and norfluoxetine across childbearing. J Clin Psychopharmacol. 2010 Aug;30(4):381-6. doi: 10.1097/JCP.0b013e3181e7be23.
- Derived from this study: PubMed 19289451Wisner KL, Sit DK, Hanusa BH, Moses-Kolko EL, Bogen DL, Hunker DF, Perel JM, Jones-Ivy S, Bodnar LM, Singer LT. Major depression and antidepressant treatment: impact on pregnancy and neonatal outcomes. Am J Psychiatry. 2009 May;166(5):557-66. doi: 10.1176/appi.ajp.2008.08081170. Epub 2009 Mar 16.
- Derived from this study: PubMed 18426260Sit DK, Perel JM, Helsel JC, Wisner KL. Changes in antidepressant metabolism and dosing across pregnancy and early postpartum. J Clin Psychiatry. 2008 Apr;69(4):652-8. doi: 10.4088/jcp.v69n0419.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine L. Wisner, MD MS principal investigator
University of Pittsburgh, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SIGH-ADS (time frame: 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00279370, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2013.