View Clinical Trial (Medical Research Study)
Postpartum Depression: Transdermal Estradiol Versus Sertraline
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Postpartum Depression |
| Purpose: |
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The purpose of this study is to determine whether estrogen patches are effective for the
treatment of postpartum major depression, as compared to sertraline (Zoloft) and placebo.
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| Study Summary: |
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This study aims to advance our therapeutic armamentarium by evaluating the efficacy of
estradiol (E2) therapy for Postpartum Major Depression (PPMD), which has received minimal
research attention in America. The design of the proposed study is an 8 week randomized
double-blind clinical trial of SERT vs. E2 vs. Placebo. Responders enter a continuation
phase with the blind intact through 6.5 months postpartum. The primary aims of this
investigation are to: 1) Test the efficacy of E2 compared to placebo for the treatment of
PPMD. Sertraline will be included as an active comparator. We have powered the study to test
for differences among the three groups and also test for differences between the E2 and
placebo group. We will test the hypothesis that E2 will be significantly more effective than
placebo and that SERT will be significantly more effective than placebo. 2) Evaluate
developmental outcomes in infants exposed to the disorder, PPMD, and the medications (SERT,
exogenous E2 or Placebo) which may be transmitted to the infants through breastfeeding. All
infants in this study will have exposure to mothers with depression. We will assess maternal
depression, mother-infant serum SERT and E2 levels and relate them to mother-infant
interactional quality and infant developmental outcomes on the Bayley Scales of Infant
Development. These data will enhance the sophistication of risk-benefit analyses for
pharmacotherapy during lactation.
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| Criteria: |
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Inclusion Criteria:
- Ages 18-45 years
- Postpartum Major depression with pregnancy or postpartum onset, intake by 3 months of
delivery.
- SIGH-ADS score >= 18 and DSM-IV Diagnosis of major depression, current, outpatient
care
- Medically healthy, including normal lipid profile, renal function, liver function,
thyroid function, and CBC
Exclusion Criteria:
- Current use of other therapies for depression, such as antidepressants,
psychotherapy, bright light therapy, and herbal remedies such as Hypericum St. John's
Wort
- DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode; substance abuse
within last 6 months
- Previous adverse reaction to sertraline or provera
- No pediatric care: No pediatrician with whom to coordinate breastfeeding and infant
care
- Use of medications for medical disorders, except for treatment of hypothyroidism or
inhalers for asthma or progestin-only contraceptives
- Heavy smoking (>10 cigarettes per day) or intent to resume heavy smoking
- hyperlipidemia
- hypertension
- personal history thromboembolic event, hypercoagulability, or first degree relatives
with thromboembolic events.
- Current or past personal history of breast, uterine, or ovarian cancer.
- First degree family history of premenopausal breast cancer or bilateral breast
cancer; >3 family members with postmenopausal breast cancer.
- Current migraine headache disorder that is either complex in nature or is accompanied
by hypertension or obesity.
- Arterial vascular disease and/or heart disease: increased risk of stroke.
- Liver disease: increased risk of biliary stones, cholestatic jaundice and benign
hepatic lesions with E2 treatment.
- Pregnancy
- Infants born <=31 weeks of gestation
- Imminent suicidality and/or homicidality: in need of higher level of care than is
provided in this study.
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| NCT ID: |
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NCT00744328 |
| Primary Contact: |
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Principal Investigator
Katherine L Wisner, MD, MS
University of Pittsburgh
Elizabeth C Nuhfer
Phone: 800-436-2461 ext. 412-683-73
Email: nuhferec@upmc.edu
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| Backup Contact: |
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Email: schomerkj@upmc.edu
Karen Schomer
Phone: 1-800-436-2461
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| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Elizabeth C Nuhfer
Phone: 412-683-7367
Email: nuhferec@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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