Effectiveness of Supplemental Calcium in Preventing Postpartum Depression

Sponsor

Oregon Health and Science University (Other)

Overall Status

Completed

CT.gov ID

NCT00228033

Collaborator

National Institute of Mental Health (NIMH) (NIH)

238

Enrollment

Location

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the effectiveness of taking supplemental calcium while pregnant in reducing the risk of postpartum depression.

Condition or Disease	Intervention/Treatment	Phase
Depression Depression, Postpartum	Drug: Elemental calcium (as carbonate)	Phase 4

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

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Prevention

Official Title:

Calcium for the Prevention of Postpartum Depression

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Calcium effects on depression; measured througout pregnancy []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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)

Exclusion Criteria:

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
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