DepressionPhase 4NCT00228033
Effectiveness of Supplemental Calcium in Preventing Postpartum Depression
A Phase 4 study testing Elemental calcium (as carbonate) in people with Depression and Depression, Postpartum, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression, Postpartum
- What is being tested?
- Elemental calcium (as carbonate)
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Aug 2007
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Less than 26 weeks pregnant
- At risk for postpartum depression due to a family or personal history of depression or history of premenstrual dysphoric disorder (PMDD)
Who cannot join
- Currently depressed
- Currently taking medications for depression, bipolar disorder, or schizophrenia
- History of medication treatment for depression within 3 months of study entry
- Any of the following illnesses: diabetes, kidney disease, parathyroid disease, or untreated thyroid disease
- Currently taking a diuretic or calcium channel blocker
- Does not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239-3098
About this study
Official title: Calcium for the Prevention of Postpartum Depression
This study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression.
Read the detailed description
Postpartum depression is a combination of physical, emotional, and behavioral changes that occur after childbirth. The rapid drop in estrogen and progesterone levels, as well as the social and psychological changes resulting from the birth of a child, can often trigger depression in women. Common symptoms include crying, irritability, fatigue, loss of appetite, and feelings of guilt and anxiety. Women who develop postpartum depression often feel unable to care for their baby or themselves. Postpartum depression is common; it is estimated that about 10 percent of new mothers experience some symptoms of depression following delivery. Risk factors include a personal or family history of depression and a history of suffering from premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS). The purpose of this study is to evaluate the effectiveness of calcium supplements taken during pregnancy in reducing the likelihood of postpartum depression in women at risk for developing this condition.
Pregnant women who are at risk for developing postpartum depression will be enrolled in this study when they are between 16 to 26 weeks pregnant. All recruited women will undergo psychological testing for screening purposes. Women who are found to be depressed or suffering from other psychiatric disorders during screening will be referred to alternative treatment and will not be enrolled in this study. All participants will then be randomly assigned to receive either a calcium supplement (2 grams) or placebo on a daily basis. Treatments will continue throughout the remainder of each woman's pregnancy and for 12 weeks after she gives birth. Outcome measurements will include standardized questionnaires and psychiatric interviews to assess depression levels. If any participant exhibits significant depressive symptoms, she will be referred for psychiatric treatment. All measurements will be assessed at Weeks 26, 32 and 38 of the pregnancy, and 6 and 12 weeks after giving birth.
- Conditions
- Depression, Depression, Postpartum
- Being tested
- Elemental calcium (as carbonate)
- Keywords
- Calcium, Pregnancy, Postpartum Depression, Depression
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elemental calcium (as carbonate)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Edinburgh Postnatal Depression Scale; measured at Weeks 6 and 12 after childbirth
Symptoms of depression; measured throughout the study with a standard psychiatric interview
Secondary outcomes (1)
Calcium effects on depression; measured througout pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startApr 2002
- Primary completionDec 2005
- Study completionAug 2007
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 DepressionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 238 participants
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Daniel C. Hatton, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228033
- Sponsor's protocol ID
- R21MH063242
- Other IDs
- R21MH063242, DAHBR AD-D
- Status last verified
- Dec 2007
- First submitted
- 26 Sep 2005
- Last updated
- 20 Mar 2014
- Results posted
- No
Publications
Harrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron D, Hatton D. Prenatal calcium supplementation and postpartum depression; an ancillary study to randomized trial of calcium for prevention of preeclampsia. Archives of Women's Mental Health 3(41):141-146, 2001.
Hatton DC, Harrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron DA. Symptoms of postpartum depression and breastfeeding. J Hum Lact. 2005 Nov;21(4):444-9; quiz 450-4. doi: 10.1177/0890334405280947.
PubMed 16280561Hatton DC, Harrison-Hohner J, Matarazzo J, Edwards P, Lewy A, Davis L. Missed antenatal depression among high risk women: a secondary analysis. Arch Womens Ment Health. 2007;10(3):121-3. doi: 10.1007/s00737-007-0180-1. Epub 2007 Apr 16.
PubMed 17431740
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium for the Prevention of Postpartum Depression
- ClinicalTrials.gov ID
- NCT00228033
- Acronym / sponsor ID
- R21MH063242
- Conditions
- Depression, Depression, Postpartum
- Keywords
- Calcium, Pregnancy, Postpartum Depression, Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 28 Sep 2005 (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 will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression.
Detailed description
Postpartum depression is a combination of physical, emotional, and behavioral changes that occur after childbirth. The rapid drop in estrogen and progesterone levels, as well as the social and psychological changes resulting from the birth of a child, can often trigger depression in women. Common symptoms include crying, irritability, fatigue, loss of appetite, and feelings of guilt and anxiety. Women who develop postpartum depression often feel unable to care for their baby or themselves. Postpartum depression is common; it is estimated that about 10 percent of new mothers experience some symptoms of depression following delivery. Risk factors include a personal or family history of depression and a history of suffering from premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome (PMS). The purpose of this study is to evaluate the effectiveness of calcium supplements taken during pregnancy in reducing the likelihood of postpartum depression in women at risk for developing this condition.
Pregnant women who are at risk for developing postpartum depression will be enrolled in this study when they are between 16 to 26 weeks pregnant. All recruited women will undergo psychological testing for screening purposes. Women who are found to be depressed or suffering from other psychiatric disorders during screening will be referred to alternative treatment and will not be enrolled in this study. All participants will then be randomly assigned to receive either a calcium supplement (2 grams) or placebo on a daily basis. Treatments will continue throughout the remainder of each woman's pregnancy and for 12 weeks after she gives birth. Outcome measurements will include standardized questionnaires and psychiatric interviews to assess depression levels. If any participant exhibits significant depressive symptoms, she will be referred for psychiatric treatment. All measurements will be assessed at Weeks 26, 32 and 38 of the pregnancy, and 6 and 12 weeks after giving birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Less than 26 weeks pregnant
- At risk for postpartum depression due to a family or personal history of depression or history of premenstrual dysphoric disorder (PMDD)
Key exclusion criteria (6 listed)
- Currently depressed
- Currently taking medications for depression, bipolar disorder, or schizophrenia
- History of medication treatment for depression within 3 months of study entry
- Any of the following illnesses: diabetes, kidney disease, parathyroid disease, or untreated thyroid disease
- Currently taking a diuretic or calcium channel blocker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elemental calcium (as carbonate) | Drug | – |
Primary outcome
Score on Edinburgh Postnatal Depression Scale; measured at Weeks 6 and 12 after childbirth
Symptoms of depression; measured throughout the study with a standard psychiatric interview
1 secondary outcome
Calcium effects on depression; measured througout pregnancy
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 20 Mar 2014.
- BackgroundHarrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron D, Hatton D. Prenatal calcium supplementation and postpartum depression; an ancillary study to randomized trial of calcium for prevention of preeclampsia. Archives of Women's Mental Health 3(41):141-146, 2001.
- Background: PubMed 16280561Hatton DC, Harrison-Hohner J, Coste S, Dorato V, Curet LB, McCarron DA. Symptoms of postpartum depression and breastfeeding. J Hum Lact. 2005 Nov;21(4):444-9; quiz 450-4. doi: 10.1177/0890334405280947.
- Results publication: PubMed 17431740Hatton DC, Harrison-Hohner J, Matarazzo J, Edwards P, Lewy A, Davis L. Missed antenatal depression among high risk women: a secondary analysis. Arch Womens Ment Health. 2007;10(3):121-3. doi: 10.1007/s00737-007-0180-1. Epub 2007 Apr 16.
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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.
Daniel C. Hatton, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elemental calcium (as carbonate) in people with Depression and Depression, Postpartum, run by Oregon Health and Science University 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 2 inclusion and 6 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 20 Mar 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Score on Edinburgh Postnatal Depression Scale; measured at Weeks 6 and 12 after childbirth. The study lists 2 primary outcomes in all. 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 NCT00228033, 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 20 Mar 2014.