Bipolar DisorderNCT00720395
Identifying Predictors of Bipolar Disorder Relapse During Pregnancy and the Postpartum Period
An observational study of Bipolar Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder 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
- Bipolar Disorder
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jul 2011
- 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: This study will include women who are pregnant or recently gave birth and who meet DSM-IV criteria for any subtype of bipolar disorder.
Who may be able to join
- Medically healthy
- Meets DSM-IV criteria for bipolar disorder of any subtype
- No more than 32 weeks gestation, dated by last menstrual period
Who cannot join
- Active suicidality or homicidality
- Acute psychotic symptoms
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University Department of Psychaitry and Behavioral Sciences
Atlanta, Georgia, 30322
About this study
Official title: Predictors of Postpartum Relapse in Women With Bipolar Disorder
This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.
Read the detailed description
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes significant changes in a person's mood and energy. The onset of bipolar disorder usually occurs during young adulthood and persists for the rest of a person's life, making women who are of childbearing age at risk for this disorder. Although overall relapse rates for pre-existing mood disorders are typically higher in women who are pregnant or recently gave birth than in other women, very little is known about the impact of pregnancy and the postpartum period on someone with bipolar disorder. The course and treatment of maternal mental illness during pregnancy and the postpartum period remains the center of much debate, particularly with respect to the use of psychotropic medications during pregnancy and breastfeeding. Identifying predictors of bipolar disorder recurrence during pregnancy and the postpartum period may help to determine which women are at highest risk and to develop new treatment guidelines. However, more information is needed to both identify predictors and develop guidelines that will improve outcomes for pregnant women with bipolar disorder and their babies. This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.
Participation in this study will last up to 6 months postpartum. Study visits will be scheduled every 4 weeks during pregnancy and every 6 weeks after delivery for up to 6 months postpartum. During study visits, data will be collected on factors that may predict bipolar disorder recurrence and overall burden of bipolar disorder illness. Specific potential factors that will be evaluated include severity of illness in the past, type and severity of both recent and past life stressors, and any treatment received during pregnancy and the postpartum period. The study will also evaluate how antidepressant medications, if taken, affect the mother and baby during pregnancy and the postpartum period. Additionally, plasma, serum, and urine samples will also be processed and stored at each study visit.
- Conditions
- Bipolar Disorder
- Keywords
- Psychiatry, Pregnancy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women with bipolar disorder who are preconception or pregnant. Primary focus on predictors of postpartum bipolar disorder relapse and burden of illness through first six months postpartum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness
Measured: Measured at Year 1 postpartum
Secondary outcomes (1)
Impact of predelivery expectations, the role of breastfeeding, and self-reported sleep disturbance in the risk for postpartum bipolar disorder relapse
Measured: Measured at Year 1 postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startAug 2005
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: Withdrawn \[Funding was never granted for this study. No participants were ever enrolled.\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Donald J. Newport, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720395
- Sponsor's protocol ID
- R01 MH085026
- Other IDs
- DATR A2-AIE
- Status last verified
- Mar 2009
- First submitted
- 18 Jul 2008
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Postpartum Relapse in Women With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00720395
- Acronym / sponsor ID
- R01 MH085026
- Conditions
- Bipolar Disorder
- Keywords
- Psychiatry, Pregnancy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawn \[Funding was never granted for this study. No participants were ever enrolled.\]
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Aug 2005
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 22 Jul 2008 (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 evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.
Detailed description
Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes significant changes in a person's mood and energy. The onset of bipolar disorder usually occurs during young adulthood and persists for the rest of a person's life, making women who are of childbearing age at risk for this disorder. Although overall relapse rates for pre-existing mood disorders are typically higher in women who are pregnant or recently gave birth than in other women, very little is known about the impact of pregnancy and the postpartum period on someone with bipolar disorder. The course and treatment of maternal mental illness during pregnancy and the postpartum period remains the center of much debate, particularly with respect to the use of psychotropic medications during pregnancy and breastfeeding. Identifying predictors of bipolar disorder recurrence during pregnancy and the postpartum period may help to determine which women are at highest risk and to develop new treatment guidelines. However, more information is needed to both identify predictors and develop guidelines that will improve outcomes for pregnant women with bipolar disorder and their babies. This study will evaluate pregnant women who have bipolar disorder to gain a better understanding of risk factors for bipolar disorder relapse during pregnancy and the postpartum period.
Participation in this study will last up to 6 months postpartum. Study visits will be scheduled every 4 weeks during pregnancy and every 6 weeks after delivery for up to 6 months postpartum. During study visits, data will be collected on factors that may predict bipolar disorder recurrence and overall burden of bipolar disorder illness. Specific potential factors that will be evaluated include severity of illness in the past, type and severity of both recent and past life stressors, and any treatment received during pregnancy and the postpartum period. The study will also evaluate how antidepressant medications, if taken, affect the mother and baby during pregnancy and the postpartum period. Additionally, plasma, serum, and urine samples will also be processed and stored at each study visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Women with bipolar disorder who are preconception or pregnant. Primary focus on predictors of postpartum bipolar disorder relapse and burden of illness through first six months postpartum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include women who are pregnant or recently gave birth and who meet DSM-IV criteria for any subtype of bipolar disorder.
Key inclusion criteria (3 listed)
- Medically healthy
- Meets DSM-IV criteria for bipolar disorder of any subtype
- No more than 32 weeks gestation, dated by last menstrual period
Key exclusion criteria (2 listed)
- Active suicidality or homicidality
- Acute psychotic symptoms
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
Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness
Time frame: Measured at Year 1 postpartum
1 secondary outcome
Impact of predelivery expectations, the role of breastfeeding, and self-reported sleep disturbance in the risk for postpartum bipolar disorder relapse
Time frame: Measured at Year 1 postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
- Click here for more information on this study at Emory University's Women's Mental Health Program siteLink 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.
Donald J. Newport, MD principal investigator
Emory University
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 Bipolar Disorder, run by National Institute of Mental Health (NIMH) 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 May 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Preconception, predelivery, and postpartum predictors of postpartum bipolar disorder relapse and burden of illness (time frame: Measured at Year 1 postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2015.