Postpartum Thyroid Measures and Mood

This study has been completed.

First Received: November 27, 2007 Last Updated: January 26, 2010 History of Changes

Sponsor:	Oklahoma State University Center for Health Sciences
Information provided by:	Oklahoma State University Center for Health Sciences
ClinicalTrials.gov Identifier:	NCT00565032

Purpose

Women with abnormal serum thyroid antibody levels or abnormal TSH and/or T4 values are more likely than their normal counterparts to have higher scores on a common postpartum depression screening test.

Condition
Postpartum Depression

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Postpartum Thyroid Measures and Mood

Resource links provided by NLM:

MedlinePlus related topics: Depression Postpartum Care Postpartum Depression

Drug Information available for: Thyroid

U.S. FDA Resources

Further study details as provided by Oklahoma State University Center for Health Sciences:

Primary Outcome Measures:

Numerical score on the Edinburgh Postnatal Depression Scale [ Time Frame: seven weeks ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	75
Study Start Date:	January 2000
Study Completion Date:	August 2001

Detailed Description:

This small pilot study was an attempt to corroborate a relationship between quantified mood and thyroid measures, using the numerical scores obtained from a common depression screen, the Edinburgh Postnatal Depression Scale (EPDS), as a continuum. Mood scores were compared with presence of thyroid autoantibodies and plasma concentrations of free T4 and TSH.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects were patients from two Oklahoma State University Center for Health Sciences (OSUCHS) clinics in Tulsa, Oklahoma.

Criteria

Inclusion Criteria:

Over 18 years of age
In third trimester of pregnancy when recruited
Negative for the following drugs detected by a urine drug screen:
- Amphetamines
- Barbiturates
- Benzodiazepines
- Cocaine
- Opiates
- Phencyclidine metabolites (PCP), and tricyclic antidepressants
- Vaginal delivery
- Screened negative for major depressive disorder on the Edinburgh Postnatal Depression Scale (EPDS) at her prenatal enrollment in the study
- Receiving a score of 12 or lower out of a possible 30

Exclusion Criteria:

Under age 18
Positive for any of the following drugs:
- Amphetamines
- Barbiturates
- Benzodiazepines
- Cocaine
- Opiates
- Phencyclidine metabolites (PCP), and tricyclic antidepressants
- Cesarean delivery
- EPDS score over 12 at prenatal screening test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565032

Locations

United States, Oklahoma
Oklahoma State University Center for Health Sciences Houston Park Obstetrics Clinic
Tulsa, Oklahoma, United States, 74107

Sponsors and Collaborators

Oklahoma State University Center for Health Sciences

Investigators

Study Director:

Gary H. Watson, PhD

Philadelphia College of Osteopathic Medicine Georgia Campus

More Information

No publications provided by Oklahoma State University Center for Health Sciences

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

McCoy SJ, Beal JM, Payton ME, Stewart AL, DeMers AM, Watson GH. Postpartum thyroid measures and depressive symptomology: a pilot study. J Am Osteopath Assoc. 2008 Sep;108(9):503-7.

Study ID Numbers:	9899015
Study First Received:	November 27, 2007
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00565032 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oklahoma State University Center for Health Sciences:

postpartum depression
thyroxine
thyroid antibodies
thyroid stimulating hormone
Edinburgh Postnatal Depression Scale (EPDS)

Additional relevant MeSH terms:

Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum

Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 08, 2010