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Antimanic Drug Use in Pregnancy

NCT ID: NCT00585702

Last Updated: 2013-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

201 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bipolar Disorder Pregnancy

Keywords

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Bipolar Disorder Pregnancy Infant Development

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Pregnant women with bipolar disorder

No interventions assigned to this group

2

Pregnant women without bipolar disorder

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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
* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Katherine Wisner

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katherine L Wisner, MD MS

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, School of Medicine, University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30248632 (View on PubMed)

Yang 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.

Reference Type DERIVED
PMID: 28570796 (View on PubMed)

Santucci 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.

Reference Type DERIVED
PMID: 28068465 (View on PubMed)

Kim 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.

Reference Type DERIVED
PMID: 26692255 (View on PubMed)

Other Identifiers

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1R01MH075921

Identifier Type: NIH

Identifier Source: secondary_id

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1R01MH075921

Identifier Type: NIH

Identifier Source: org_study_id

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