Postpartum DepressionNCT00056901
Screening Evaluation for Women With Postpartum Depression
An observational study of Postpartum Depression and Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study evaluates the relationship between mood changes and hormones in women with postpartum depression (PPD). This is an observational study; volunteers who participate will not receive any new or experimental therapies. PPD is similar to major depression, but develops around the time a woman gives birth. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression, Depression
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2003to 24 Dec 2017
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Cross-sectional Screening: The postpartum subjects of this protocol will be women who meet the following inclusion criteria:
- History of at least two weeks with postpartum-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a mild to moderate degree of functional impairment;
- The onset of mood symptoms occurred within three months of delivery;
- Age 20-45; The selection of the lower limit of this age window is intended to reduce the potential confound that the psychosocial stress of a teenage pregnancy could complicate the relationship between postpartum hormonal events and mood. The upper age limit was selected since pregnancy and childbirth in a woman over this age range could lead to spontaneous menopause and, therefore, our ability to discern the effects of estrogen therapy on mood could be complicated by estrogen s effects on menopausal symptoms.
- History of normal delivery (vaginal or caesarean) within last six months;
- No prior estrogen replacement therapy for treatment of postpartum physical or emotional symptoms within the last six months;
Show all 16Show fewer
- In good medical health.
- Subjects must be competent to comprehend the purpose of the screening process and to provide written informed consent and be willing to participate in NIMH IRB approved research protocols.
- A control group of age-matched postpartum women who meet patient selection criteria with the exception of the presence of mood or behavioral disorders will also be sought.
- Pregnant;
- Absence of current mood or behavioral disturbance as determined by a structured diagnostic interview;
- Past history of postpartum depression;
- In good medical health,
- Medication free.
- GENETIC STUDIES:
- Unaffected family members of women with PPD will be admitted for genetic studies only who are first degree relatives of women with confirmed PPD, and who do not have PPD as defined in this protocol.
Who cannot join
- Current antidepressant therapy
- Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);
- Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
- This protocol is a screening protocol for an estradiol treatment study (03-M-0161) for which the exclusion criteria include the current use of antidepressant medications. However, antidepressants will not be withheld from subjects who need or want them. Immediately after screening subjects will either be enrolled in the estrogen treatment study or in traditional therapy until care can be transitioned to the community. There are few exclusion criteria for the evaluation component of this protocol; however, all women will undergo a structured diagnostic interview Those women who will be asked to participate in the companion protocol evaluating the efficacy of estradiol administration in PPD will meet either research diagnostic criteria for minor depression with at least three core symptoms (SADS-L (90) or major depression (SCID-IV) (91) of not greater than moderate severity on the Global Assessment of Functioning Scale (GAF) (91)) and will not meet DSM-IV criteria # 9 (suicide) or require immediate treatment. Subjects meeting major depression with greater than moderate severity may participate in the evaluation phase of this study but will be offered a referral to an outside facility for standard antidepressant treatment (i.e., they are not candidates for participation in the IRB approved treatment protocol).
- LONGITUDINAL SCREENING:
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Screening Protocol to Evaluate Women With Postpartum-Related Mood and Behavioral Disorders
This study evaluates the relationship between mood changes and hormones in women with postpartum depression (PPD).
This is an observational study; volunteers who participate will not receive any new or experimental therapies.
Read more
PPD is similar to major depression, but develops around the time a woman gives birth. Women with PPD often suffer serious physical and emotional impairments. Controversy exists regarding the role of hormone changes in postpartum depression. This study will examine the role of hormone changes in three groups of women: those who recently gave birth and have mild to moderately severe PDD (Group 1), women who recently gave birth and do not have PDD (Group 2), and those who are currently pregnant and experienced an episode of PDD with a previous birth (Group 3).
Participants will be screened with a medical history, physical examination, and blood and urine tests. Upon study entry, they will be interviewed about their moods, behaviors, and medical status during and immediately following their last pregnancy. Some women will be asked to participate in interviews, psychological tests, and blood tests. They will also complete self-rating scales and may be asked to collect samples of their urine. Women in Group 3 will complete self-rating scales for 6 months postpartum. Participants will participate in genetic studies that involve completing a questionnaire and providing a blood sample. If the participant allows, sisters and parents may be asked to provide a blood sample and undergo a psychiatric interview.
Participants who meet the criteria for minor depression or major depression that is no greater than moderate severity will be asked to participate in a companion study that will evaluate the effectiveness of estradiol in reducing depression symptoms.
...
Read the detailed description
Controversy exists regarding the relevance of changes in gonadal steroids for postpartum-onset depressions. The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols that examine the role of gonadal steroids in postpartum-onset depressions (PPD) and for the collection of natural history data. Women in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other PPD protocols (e.g., DNA, psychophysiology tests, treatment studies, etc.) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of women with PPD. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The second purpose of this protocol is to permit the identification of pregnant women who are at risk for developing postpartum depression (PPD), and who are followed longitudinally through the postpartum in an effort to confirm the association of depression onset with change in reproductive endocrine function. This protocol, then, serves as a screening and evaluation protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies.
- Conditions
- Postpartum Depression, Depression
- Keywords
- Puerperium, Pregnancy, Mood Disorders, Estradiol, Progesterone, Mood, Behavior, Cognition, Perimenopause, Menopause, Post Partum Depression, PPD, Healthy Volunteer, HV
- Medical subject headings
- Depression, Postpartum, Depression, Mood Disorders, Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2003 (estimated)
- Study start25 Mar 2003
- Study completion24 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter J Schmidt, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056901
- Sponsor's protocol ID
- 030138
- Other IDs
- 03-M-0138
- Status last verified
- 24 Dec 2017
- First submitted
- 26 Mar 2003
- Last updated
- 14 Feb 2018
- Results posted
- No
Publications
Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. doi: 10.1192/bjp.144.1.35.
PubMed 6692075Cox JL, Murray D, Chapman G. A controlled study of the onset, duration and prevalence of postnatal depression. Br J Psychiatry. 1993 Jul;163:27-31. doi: 10.1192/bjp.163.1.27.
PubMed 8353695O'Hara MW, Schlechte JA, Lewis DA, Varner MW. Controlled prospective study of postpartum mood disorders: psychological, environmental, and hormonal variables. J Abnorm Psychol. 1991 Feb;100(1):63-73. doi: 10.1037//0021-843x.100.1.63.
PubMed 2005273
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Screening Protocol to Evaluate Women With Postpartum-Related Mood and Behavioral Disorders
- ClinicalTrials.gov ID
- NCT00056901
- Acronym / sponsor ID
- 030138
- Conditions
- Postpartum Depression, Depression
- Keywords
- Puerperium, Pregnancy, Mood Disorders, Estradiol, Progesterone, Mood, Behavior, Cognition
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 25 Mar 2003
- Study completion
- 24 Dec 2017
- First posted
- 26 Mar 2003 (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.
This study evaluates the relationship between mood changes and hormones in women with postpartum depression (PPD).
This is an observational study; volunteers who participate will not receive any new or experimental therapies.
PPD is similar to major depression, but develops around the time a woman gives birth. Women with PPD often suffer serious physical and emotional impairments. Controversy exists regarding the role of hormone changes in postpartum depression. This study will examine the role of hormone changes in three groups of women: those who recently gave birth and have mild to moderately severe PDD (Group 1), women who recently gave birth and do not have PDD (Group 2), and those who are currently pregnant and experienced an episode of PDD with a previous birth (Group 3).
Participants will be screened with a medical history, physical examination, and blood and urine tests. Upon study entry, they will be interviewed about their moods, behaviors, and medical status during and immediately following their last pregnancy. Some women will be asked to participate in interviews, psychological tests, and blood tests. They will also complete self-rating scales and may be asked to collect samples of their urine. Women in Group 3 will complete self-rating scales for 6 months postpartum. Participants will participate in genetic studies that involve completing a questionnaire and providing a blood sample. If the participant allows, sisters and parents may be asked to provide a blood sample and undergo a psychiatric interview.
Participants who meet the criteria for minor depression or major depression that is no greater than moderate severity will be asked to participate in a companion study that will evaluate the effectiveness of estradiol in reducing depression symptoms.
...
Detailed description
Controversy exists regarding the relevance of changes in gonadal steroids for postpartum-onset depressions. The purpose of this protocol is to allow for the careful screening of patients and healthy volunteers for participation in research protocols that examine the role of gonadal steroids in postpartum-onset depressions (PPD) and for the collection of natural history data. Women in this protocol will undergo an evaluation which may include: a psychiatric interview; a diagnostic interview; rating scales; a medical history; a physical exam; blood and urine laboratory evaluation; and a request for medical records. The data collected may also be linked with data from other PPD protocols (e.g., DNA, psychophysiology tests, treatment studies, etc.) for the purposes of better understanding the diagnosis, pathophysiology, and treatment response of women with PPD. Upon conclusion of the screening process, subjects will either be offered participation in a research protocol and will sign the appropriate informed consent, or will be considered not appropriate for participation in research and will be referred back into the community. The second purpose of this protocol is to permit the identification of pregnant women who are at risk for developing postpartum depression (PPD), and who are followed longitudinally through the postpartum in an effort to confirm the association of depression onset with change in reproductive endocrine function. This protocol, then, serves as a screening and evaluation protocol to recruit subjects who are characterized with standard measures in this protocol and then offered participation in related studies.
Study design
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Cross-sectional Screening: The postpartum subjects of this protocol will be women who meet the following inclusion criteria:
- History of at least two weeks with postpartum-related mood or behavioral disturbances of at least moderate severity - that is, disturbances that are distinct in appearance and associated with a mild to moderate degree of functional impairment;
- The onset of mood symptoms occurred within three months of delivery;
- Age 20-45; The selection of the lower limit of this age window is intended to reduce the potential confound that the psychosocial stress of a teenage pregnancy could complicate the relationship between postpartum hormonal events and mood. The upper age limit was selected since pregnancy and childbirth in a woman over this age range could lead to spontaneous menopause and, therefore, our ability to discern the effects of estrogen therapy on mood could be complicated by estrogen s effects on menopausal symptoms.
- History of normal delivery (vaginal or caesarean) within last six months;
Key exclusion criteria (5 listed)
- Current antidepressant therapy
- Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder);
- Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups).
- This protocol is a screening protocol for an estradiol treatment study (03-M-0161) for which the exclusion criteria include the current use of antidepressant medications. However, antidepressants will not be withheld from subjects who need or want them. Immediately after screening subjects will either be enrolled in the estrogen treatment study or in traditional therapy until care can be transitioned to the community. There are few exclusion criteria for the evaluation component of this protocol; however, all women will undergo a structured diagnostic interview Those women who will be asked to participate in the companion protocol evaluating the efficacy of estradiol administration in PPD will meet either research diagnostic criteria for minor depression with at least three core symptoms (SADS-L (90) or major depression (SCID-IV) (91) of not greater than moderate severity on the Global Assessment of Functioning Scale (GAF) (91)) and will not meet DSM-IV criteria # 9 (suicide) or require immediate treatment. Subjects meeting major depression with greater than moderate severity may participate in the evaluation phase of this study but will be offered a referral to an outside facility for standard antidepressant treatment (i.e., they are not candidates for participation in the IRB approved treatment protocol).
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 6692075Kumar R, Robson KM. A prospective study of emotional disorders in childbearing women. Br J Psychiatry. 1984 Jan;144:35-47. doi: 10.1192/bjp.144.1.35.
- Background: PubMed 8353695Cox JL, Murray D, Chapman G. A controlled study of the onset, duration and prevalence of postnatal depression. Br J Psychiatry. 1993 Jul;163:27-31. doi: 10.1192/bjp.163.1.27.
- Background: PubMed 2005273O'Hara MW, Schlechte JA, Lewis DA, Varner MW. Controlled prospective study of postpartum mood disorders: psychological, environmental, and hormonal variables. J Abnorm Psychol. 1991 Feb;100(1):63-73. doi: 10.1037//0021-843x.100.1.63.
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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.
Peter J Schmidt, M.D. principal investigator
National Institute of Mental Health (NIMH)
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 and Depression, run by National Institute of Mental Health (NIMH) 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 16 inclusion and 5 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: stopped early, as of the sponsor's last update on 14 Feb 2018. 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056901, which also lists 3 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 14 Feb 2018.