Postpartum DepressionNCT00565032
Postpartum Thyroid Measures and Mood
An observational study of Postpartum Depression, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Aug 2001
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Subjects were patients from two Oklahoma State University Center for Health Sciences (OSUCHS) clinics in Tulsa, Oklahoma.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Under age 18
- Positive for any of the following drugs:
- Amphetamines
- Barbiturates
- Benzodiazepines
- Cocaine
Show all 10Show fewer
- Opiates
- Phencyclidine metabolites (PCP), and tricyclic antidepressants
- Cesarean delivery
- EPDS score over 12 at prenatal screening test
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University Center for Health Sciences Houston Park Obstetrics Clinic
Tulsa, Oklahoma, 74107
About this study
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.
Read the 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.
- Conditions
- Postpartum Depression
- Keywords
- postpartum depression, thyroxine, thyroid antibodies, thyroid stimulating hormone, Edinburgh Postnatal Depression Scale (EPDS)
- Medical subject headings
- Depression, Postpartum
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical score on the Edinburgh Postnatal Depression Scale
Measured: seven weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startJan 2000
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Gary H. Watson, PhD, Study director, Philadelphia College of Osteopathic Medicine Georgia Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565032
- Sponsor's protocol ID
- 9899015
- Status last verified
- Jan 2010
- First submitted
- 27 Nov 2007
- Last updated
- 28 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18806079
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Thyroid Measures and Mood
- ClinicalTrials.gov ID
- NCT00565032
- Acronym / sponsor ID
- 9899015
- Conditions
- Postpartum Depression
- Keywords
- postpartum depression, thyroxine, thyroid antibodies, thyroid stimulating hormone, Edinburgh Postnatal Depression Scale (EPDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- Jan 2000
- Study completion
- Aug 2001 (actual)
- First posted
- 29 Nov 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects were patients from two Oklahoma State University Center for Health Sciences (OSUCHS) clinics in Tulsa, Oklahoma.
Key inclusion criteria (12 listed)
- Over 18 years of age
- In third trimester of pregnancy when recruited
- Negative for the following drugs detected by a urine drug screen:
Key exclusion criteria (10 listed)
- Under age 18
- Positive for any of the following drugs:
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
Numerical score on the Edinburgh Postnatal Depression Scale
Time frame: seven weeks
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 28 Jan 2010.
- Derived from this study: PubMed 18806079McCoy 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.
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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.
Gary H. Watson, PhD study director
Philadelphia College of Osteopathic Medicine Georgia Campus
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 Postpartum Depression, run by Oklahoma State University Center for Health Sciences 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 12 inclusion and 10 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 28 Jan 2010. 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?
Numerical score on the Edinburgh Postnatal Depression Scale (time frame: seven weeks). 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 NCT00565032, which also lists 1 linked publication.
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 28 Jan 2010.