Bipolar DisorderAMUPNCT00585702
Antimanic Drug Use in Pregnancy
An observational study of Bipolar Disorder and Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. 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
- Bipolar Disorder, Pregnancy
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Mar 2012
- 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: Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any subtype
Who may be able to join
- Age 18 or older
- Pregnant at 20 weeks or more
- Women must receive OB care
- English-speaking
- DSM-IV diagnosis of BP, any subtype
- Age 18 or older
Show all 10Show fewer
- Pregnant at 20 weeks or more
- English-speaking
- Women must receive OB care.
- Women may have past or present subclinical Major Depressive Disorder according to the DSM-IV.
Who cannot join
- Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.
- Women must not take drugs in the FDA categories D or X.
- Additional Exclusion Criteria for Control Subjects:
- Women must have no lifetime history of Bipolar Disorder or antimanic drug use.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.
- Conditions
- Bipolar Disorder, Pregnancy
- Keywords
- Bipolar Disorder, Pregnancy, Infant Development
- 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 | Pregnant women with bipolar disorder | |
| 2 | Pregnant women without bipolar disorder |
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, 2,12,28,52 weeks postpartum
Mania Rating Scale
Measured: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Bayley Scales of Infant Development
Measured: 12, 28, 52 weeks postpartum
Secondary outcomes (5)
Weight gain in pregnancy
Measured: 20,30,36 weeks gestation
Structured Clinical Interview for DSM-IV
Measured: 20 weeks gestation at enrollment
Nutritional Blood Levels
Measured: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Maternal Functioning and Gratification
Measured: 2, 12, 28, 52 weeks postpartum
Infant physical exam
Measured: 2,12,28,52 weeks post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study startAug 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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
- 201 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, Department of Psychiatry, School of Medicine, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585702
- Sponsor's protocol ID
- 1R01MH075921
- Other IDs
- 1R01MH075921
- Acronym
- AMUP
- Status last verified
- Sep 2013
- First submitted
- 28 Dec 2007
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Wisner 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 28570796Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Sit DK, Wisner KL. One-Year Developmental Outcomes for Infants of Mothers With Bipolar Disorder. J Clin Psychiatry. 2017 Sep-Oct;78(8):1083-1090. doi: 10.4088/JCP.15m10535.
PubMed 28068465Kim 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 26692255
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
- Antimanic Drug Use in Pregnancy
- ClinicalTrials.gov ID
- NCT00585702
- Acronym / sponsor ID
- AMUP / 1R01MH075921
- Conditions
- Bipolar Disorder, Pregnancy
- Keywords
- Bipolar Disorder, Pregnancy, Infant Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Jan 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.
The purpose of this study is to learn about the effects of bipolar disorder or the use of antimanic medications on the mother's health and wellbeing during pregnancy and for the first postpartum year. Infant health and development are also assessed during the first year. Participation in the study includes 7 study visits, three in pregnancy and four postpartum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pregnant women with bipolar disorder |
| 2 | – | –Pregnant women without bipolar disorder |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any subtype
Key inclusion criteria (10 listed)
- Age 18 or older
- Pregnant at 20 weeks or more
- Women must receive OB care
- English-speaking
- DSM-IV diagnosis of BP, any subtype
Key exclusion criteria (4 listed)
- Women must have no Active Alcohol Abuse or Dependence, Active Abuse or Dependence of Opiates, Inhalants, Amphetamines including Ecstasy or LSD, Active IV Drug Abuse, or Methadone Maintenance.
- Women must not take drugs in the FDA categories D or X.
- Women must have no lifetime history of Bipolar Disorder or antimanic drug use.
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, 2,12,28,52 weeks postpartum
Mania Rating Scale
Time frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Bayley Scales of Infant Development
Time frame: 12, 28, 52 weeks postpartum
5 secondary outcomes
Weight gain in pregnancy
Time frame: 20,30,36 weeks gestation
Structured Clinical Interview for DSM-IV
Time frame: 20 weeks gestation at enrollment
Nutritional Blood Levels
Time frame: 20, 30 36 weeks gestation, 2,12,28,52 weeks postpartum
Maternal Functioning and Gratification
Time frame: 2, 12, 28, 52 weeks postpartum
Infant physical exam
Time frame: 2,12,28,52 weeks post delivery
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 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 28068465Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Sit DK, Wisner KL. One-Year Developmental Outcomes for Infants of Mothers With Bipolar Disorder. J Clin Psychiatry. 2017 Sep-Oct;78(8):1083-1090. doi: 10.4088/JCP.15m10535.
- 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.
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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
Department of Psychiatry, School of Medicine, University of Pittsburgh
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 and Pregnancy, 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 10 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, 2,12,28,52 weeks postpartum). The study lists 3 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 NCT00585702, which also lists 4 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.