PregnancyNCT00864370
Bipolar Disorder (BPD) in Pregnancy: Predictors of Morbidity
An observational study of Pregnancy and Bipolar Disorder, run by Emory University at 1 site in United States.
Trial summary
Very little is known about the impact of pregnancy and the postpartum period on BPD. As a result, the investigators have little evidence on which to base treatment guidelines. The main goal of this study is to help fill this gap by finding the risk factors for BPD relapse during pregnancy and the postpartum period. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Bipolar Disorder
- How many people
- 237 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Jun 2013
- 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
- No healthy volunteers
- Adult
Study population: Women of child bearing potential meeting DSM-IV (Diagnostic and Statistical Manual - IV) criteria for any subtype of Bipolar Disorder
Who may be able to join
- Medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for BPD of any subtype who are ≥ 16 weeks gestation dated by last menstrual period (LMP)
- Able to give informed consent and comply with study procedures
Who cannot join
- Actively suicidal or homicidal
- Active substance use disorder within 6 months prior to enrollment
- Positive urine drug screen
- Hematocrit < 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Department of Psychiatry & Behavioral Sciences
Atlanta, Georgia, 30322
About this study
Official title: Bipolar Disorder in Pregnancy: Predictors of Morbidity
Very little is known about the impact of pregnancy and the postpartum period on BPD. As a result, the investigators have little evidence on which to base treatment guidelines. The main goal of this study is to help fill this gap by finding the risk factors for BPD relapse during pregnancy and the postpartum period.
The risk factors that the investigators will study include:
Read more
- the severity of illness in the past
- the type and severity of both recent and past stressors
- any treatments received during pregnancy and the postpartum period.
Other goals of the study are:
- to see what effect, if any, illness or any medicines taken during pregnancy have on the baby's well-being at delivery
- to see how pregnancy alters the way the body clears any medicines taken for BPD
- to see how much of these medicines babies are exposed to during pregnancy or breast-feeding.
The investigators believe that the information gathered in this study will lead to new treatment guidelines for BPD during pregnancy and the postpartum period that will improve outcomes for pregnant women with BPD and their babies.
Read the detailed description
Despite the significant morbidity of bipolar disorder (BPD) and its high prevalence during the childbearing years, remarkably little is known about the impact of the female reproductive life cycle on BPD. Clinicians lack evidence-based guidelines for the perinatal management of BPD. The proposal addresses an understudied area with considerable public health implications for the estimated 100,000 women with BPD who conceive each year in the US.
The broad goal of this project is to delineate the clinical, psychosocial, and in particular, pharmacologic predictors of BPD recurrence during pregnancy. Preliminary findings suggest that inadequate treatment is a particularly robust predictor of prenatal BPD recurrence. Consequently, a specific emphasis will be placed on investigating the recurrence risk associated with suboptimal pharmacotherapy occurring as a result of medication discontinuation or declining drug concentrations secondary to increased prenatal clearance.
A prospective cohort design with monthly assessments will be implemented in a collaborative investigation between two of the leading perinatal psychiatry academic centers in the US with specific expertise in mood disorders research during pregnancy. The specific aims are 1) to quantify the risks for both syndromal and subsyndromal prenatal BPD illness associated with suboptimal pharmacotherapy while controlling for the severity of the previous course of illness and recent psychosocial stressors, 2) to examine the association of maternal prenatal BPD morbidity and psychotropic exposure with infant outcome at delivery thereby filling a current void and rounding out the requisite facets of the clinical risk/benefit assessment, and 3) to conduct pharmacokinetic (PK) modeling in an effort to delineate pregnancy-associated changes in drug clearance and provide initial reliable estimates of fetal drug exposure.
Study results will represent an incremental advance that: 1) elucidates risk factors for BPD morbidity during pregnancy; 2) contributes clinically relevant data to establish therapeutic guidelines for BPD during pregnancy; and 3) serve as a basis for preventive strategies aimed at optimizing maternal and infant outcome. Furthermore, the novel PK data will expand our understanding of prenatal drug metabolism, and the project will establish a cohort of children of women with BPD with detailed prospective prenatal histories.
- Conditions
- Pregnancy, Bipolar Disorder
- Keywords
- Psychiatry, Pregnancy, Bipolar Disorder
- Medical subject headings
- Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if psychiatric morbidity among pregnant women with BPD is greatest for those who receive suboptimal pharmacotherapy, have a more severe past illness-course, or have experienced recent psychosocial stressors.
Measured: Nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startMay 2005
- Primary completionJan 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, The Cleveland Clinic
- Responsible party
- Principal investigator, Donald Jeffrey Newport, Emory University
- Investigators
- D. Jeffrey Newport, MD, Principal investigator, Emory Unviersity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864370
- Sponsor's protocol ID
- IRB00046058
- Other IDs
- R01MH071531, Bipolar Disorder in Pregnancy
- Status last verified
- Nov 2013
- First submitted
- 25 Feb 2009
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newport DJ, Baldessarini RJ, Knight BT, Fernandez SV, Morris NJ, Viguera AC, Stowe ZN. Comparison of women with confirmed versus presumably misdiagnosed bipolar disorder. J Clin Psychiatry. 2012 Feb;73(2):242-6. doi: 10.4088/JCP.11m06936. Epub 2011 Dec 27.
PubMed 22225624Johnson KC, LaPrairie JL, Brennan PA, Stowe ZN, Newport DJ. Prenatal antipsychotic exposure and neuromotor performance during infancy. Arch Gen Psychiatry. 2012 Aug;69(8):787-94. doi: 10.1001/archgenpsychiatry.2012.160.
PubMed 22474072
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Disorder in Pregnancy: Predictors of Morbidity
- ClinicalTrials.gov ID
- NCT00864370
- Acronym / sponsor ID
- IRB00046058
- Conditions
- Pregnancy, Bipolar Disorder
- Keywords
- Psychiatry, Pregnancy, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, The Cleveland Clinic
- Study start
- May 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Mar 2009 (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.
Very little is known about the impact of pregnancy and the postpartum period on BPD. As a result, the investigators have little evidence on which to base treatment guidelines. The main goal of this study is to help fill this gap by finding the risk factors for BPD relapse during pregnancy and the postpartum period.
The risk factors that the investigators will study include:
- the severity of illness in the past
- the type and severity of both recent and past stressors
- any treatments received during pregnancy and the postpartum period.
Other goals of the study are:
- to see what effect, if any, illness or any medicines taken during pregnancy have on the baby's well-being at delivery
- to see how pregnancy alters the way the body clears any medicines taken for BPD
- to see how much of these medicines babies are exposed to during pregnancy or breast-feeding.
The investigators believe that the information gathered in this study will lead to new treatment guidelines for BPD during pregnancy and the postpartum period that will improve outcomes for pregnant women with BPD and their babies.
Detailed description
Despite the significant morbidity of bipolar disorder (BPD) and its high prevalence during the childbearing years, remarkably little is known about the impact of the female reproductive life cycle on BPD. Clinicians lack evidence-based guidelines for the perinatal management of BPD. The proposal addresses an understudied area with considerable public health implications for the estimated 100,000 women with BPD who conceive each year in the US.
The broad goal of this project is to delineate the clinical, psychosocial, and in particular, pharmacologic predictors of BPD recurrence during pregnancy. Preliminary findings suggest that inadequate treatment is a particularly robust predictor of prenatal BPD recurrence. Consequently, a specific emphasis will be placed on investigating the recurrence risk associated with suboptimal pharmacotherapy occurring as a result of medication discontinuation or declining drug concentrations secondary to increased prenatal clearance.
A prospective cohort design with monthly assessments will be implemented in a collaborative investigation between two of the leading perinatal psychiatry academic centers in the US with specific expertise in mood disorders research during pregnancy. The specific aims are 1) to quantify the risks for both syndromal and subsyndromal prenatal BPD illness associated with suboptimal pharmacotherapy while controlling for the severity of the previous course of illness and recent psychosocial stressors, 2) to examine the association of maternal prenatal BPD morbidity and psychotropic exposure with infant outcome at delivery thereby filling a current void and rounding out the requisite facets of the clinical risk/benefit assessment, and 3) to conduct pharmacokinetic (PK) modeling in an effort to delineate pregnancy-associated changes in drug clearance and provide initial reliable estimates of fetal drug exposure.
Study results will represent an incremental advance that: 1) elucidates risk factors for BPD morbidity during pregnancy; 2) contributes clinically relevant data to establish therapeutic guidelines for BPD during pregnancy; and 3) serve as a basis for preventive strategies aimed at optimizing maternal and infant outcome. Furthermore, the novel PK data will expand our understanding of prenatal drug metabolism, and the project will establish a cohort of children of women with BPD with detailed prospective prenatal histories.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women of child bearing potential meeting DSM-IV (Diagnostic and Statistical Manual - IV) criteria for any subtype of Bipolar Disorder
Key inclusion criteria (2 listed)
- Medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for BPD of any subtype who are ≥ 16 weeks gestation dated by last menstrual period (LMP)
- Able to give informed consent and comply with study procedures
Key exclusion criteria (4 listed)
- Actively suicidal or homicidal
- Active substance use disorder within 6 months prior to enrollment
- Positive urine drug screen
- Hematocrit < 30
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
To determine if psychiatric morbidity among pregnant women with BPD is greatest for those who receive suboptimal pharmacotherapy, have a more severe past illness-course, or have experienced recent psychosocial stressors.
Time frame: Nine months
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 13 Nov 2013.
- Results publication: PubMed 22225624Newport DJ, Baldessarini RJ, Knight BT, Fernandez SV, Morris NJ, Viguera AC, Stowe ZN. Comparison of women with confirmed versus presumably misdiagnosed bipolar disorder. J Clin Psychiatry. 2012 Feb;73(2):242-6. doi: 10.4088/JCP.11m06936. Epub 2011 Dec 27.
- Results publication: PubMed 22474072Johnson KC, LaPrairie JL, Brennan PA, Stowe ZN, Newport DJ. Prenatal antipsychotic exposure and neuromotor performance during infancy. Arch Gen Psychiatry. 2012 Aug;69(8):787-94. doi: 10.1001/archgenpsychiatry.2012.160.
- Emory Women's Mental Health ProgramLink provided by the sponsor.
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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.
D. Jeffrey Newport, MD principal investigator
Emory Unviersity
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 Pregnancy and Bipolar Disorder, run by Emory University 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 13 Nov 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?
To determine if psychiatric morbidity among pregnant women with BPD is greatest for those who receive suboptimal pharmacotherapy, have a more severe past illness-course, or have experienced recent psychosocial stressors. (time frame: Nine months). 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 NCT00864370, which also lists 2 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 13 Nov 2013.