Bipolar DisorderNCT00580268
Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
An observational study of Bipolar Disorder and Psychiatric Morbidity, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bipolar Disorder, Psychiatric Morbidity, Neonatal Outcome
- How many people
- 118 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Jul 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: psychiatrists, referring obstetricians, community-based health centers, triage, and women who have previously given written permission to be contacted about research studies within the MGH Perinatal and Reproductive Psychiatry Program
Who may be able to join
- medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
- euthymic at the time of conception;
- able to give informed consent and comply with study procedures;
- have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45
Who cannot join
- active suicidality or homicidality;
- active substance use disorder with 6 months prior to enrollment, or
- positive urine drug screen at enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 30322
Massachusetts Geral Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.
- Conditions
- Bipolar Disorder, Psychiatric Morbidity, Neonatal Outcome
- 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 |
|---|---|---|
| H | Pregnant women with bipolar disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychiatric morbidity
Measured: 15 months
Secondary outcomes (1)
obstetrical outcomes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startAug 2005
- Primary completionDec 2010
- Study completionJul 2013
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 Massachusetts General HospitalThe 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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viguera, Adele, Massachusetts General Hospital
- Investigators
- Adele C Viguera, MD, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580268
- Sponsor's protocol ID
- 2005P001167
- Other IDs
- R01MH071762
- Status last verified
- Aug 2014
- First submitted
- 20 Dec 2007
- Last updated
- 12 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
- ClinicalTrials.gov ID
- NCT00580268
- Acronym / sponsor ID
- 2005P001167
- Conditions
- Bipolar Disorder, Psychiatric Morbidity, Neonatal Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Dec 2007 (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.
The purpose of this study is to examine risk factors for relapse of bipolar disorder during pregnancy and the postpartum period. The main goal of this study is to find the risks that may make it more likely for a woman with bipolar disorder to experience a depressive, manic, or hypomanic episode during her pregnancy and the postpartum period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H | – | –Pregnant women with bipolar disorder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- psychiatrists, referring obstetricians, community-based health centers, triage, and women who have previously given written permission to be contacted about research studies within the MGH Perinatal and Reproductive Psychiatry Program
Key inclusion criteria (4 listed)
- medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for bipolar disorder of any type (1 or 2) who are currently pregnant within 14 weeks gestation dated by last menstrual period;
- euthymic at the time of conception;
- able to give informed consent and comply with study procedures;
- have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45
Key exclusion criteria (3 listed)
- active suicidality or homicidality;
- active substance use disorder with 6 months prior to enrollment, or
- positive urine drug screen at enrollment.
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
psychiatric morbidity
Time frame: 15 months
1 secondary outcome
obstetrical outcomes
Time frame: 6 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 12 Aug 2014.
- MGH Center for Women's Mental HealthLink 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.
Adele C Viguera, MD principal investigator
MGH
2 sites 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 and Psychiatric Morbidity, run by Massachusetts General Hospital at 2 sites 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 4 inclusion and 3 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 12 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
psychiatric morbidity (time frame: 15 months). 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 12 Aug 2014.