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Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00580268
Recruitment Status : Completed
First Posted : December 24, 2007
Last Update Posted : August 12, 2014
Sponsor:
Information provided by (Responsible Party):
Viguera, Adele, Massachusetts General Hospital

Tracking Information
First Submitted Date December 20, 2007
First Posted Date December 24, 2007
Last Update Posted Date August 12, 2014
Study Start Date August 2005
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2007)
psychiatric morbidity [ Time Frame: 15 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2007)
obstetrical outcomes [ Time Frame: 6 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Official Title Bipolar Disorder in Pregnancy and the Postpartum Period: Predictors of Morbidity
Brief 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 and the postpartum period.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum, plasma, urine, whole blood, saliva, amniotic fluid, breast milk
Sampling Method Non-Probability Sample
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
Condition
  • Bipolar Disorder
  • Psychiatric Morbidity
  • Neonatal Outcome
Intervention Not Provided
Study Groups/Cohorts H
Pregnant women with bipolar disorder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 28, 2014)
118
Original Estimated Enrollment
 (submitted: December 20, 2007)
250
Actual Study Completion Date July 2013
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. 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;
  2. euthymic at the time of conception;
  3. able to give informed consent and comply with study procedures;
  4. have a treating psychiatrist, physician or mental health clinician. Gravid women between the ages of 18 and 45

Exclusion Criteria:

  1. active suicidality or homicidality;
  2. active substance use disorder with 6 months prior to enrollment, or
  3. positive urine drug screen at enrollment.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00580268
Other Study ID Numbers 2005P001167
R01MH071762 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Viguera, Adele, Massachusetts General Hospital
Original Responsible Party Adele C. Viguera, Massachusetts General Hospital
Current Study Sponsor Massachusetts General Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Adele C Viguera, MD MGH
PRS Account Massachusetts General Hospital
Verification Date August 2014