Postpartum Depression: Transdermal Estradiol Versus Sertraline (E2 SERT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Pittsburgh.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Pittsburgh
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00744328
First received: August 28, 2008
Last updated: February 17, 2011
Last verified: February 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Postpartum Depression |
Drug: Transdermal Estradiol Drug: Sertraline Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Postpartum Depression: Transdermal Estradiol Versus Sertraline |
Resource links provided by NLM:
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
Sertraline hydrochloride
Sertraline
U.S. FDA Resources
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Percent of subjects, in each treatment arm, with remission of major depressive episode [ Time Frame: yearly ] [ Designated as safety issue: No ]
- Time to remission of major depressive episode [ Time Frame: yearly ] [ Designated as safety issue: No ]
- Number of venous thromboembolic events in the 3 treatment arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- Endometrial hyperplasia cases in each treatment arm [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- Incident breast CA cases in the 3 treatment arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- Irregular vaginal bleeding in the 3 treatment arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
- Undesired breastfeeding discontinuation in the 3 treatment arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Infant development among 6.5 month old children of mothers with PPMD, as assessed by Bayley Scales of Infant development [ Time Frame: yearly ] [ Designated as safety issue: No ]
- Infant serum concentrations of estradiol in 3 treatment arms [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Estradiol
Estradiol patch ranging in dose from 50 to 200 mcg/day
|
Drug: Transdermal Estradiol
Estradiol patch ranging in dose from 50 to 200 mcg/day
Other Name: Vivelle dot
|
| Active Comparator: Sertraline |
Drug: Sertraline
Sertraline dose will range from 50 - 200 mg/day
Other Name: Zoloft
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744328
Contacts
| Contact: Elizabeth C Nuhfer | 800-436-2461 ext 412-683-7367 | nuhferec@upmc.edu |
| Contact: Karen Schomer | 1-800-436-2461 | schomerkj@upmc.edu |
Locations
| United States, Pennsylvania | |
| University of Pittsburgh School of Medicine; WPIC: Women's Behavioral HealthCARE | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Elizabeth C Nuhfer 412-683-7367 nuhferec@upmc.edu | |
| Contact: Karen Schomer 800-436-2461 schomerkj@upmc.edu | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Principal Investigator: | Katherine L Wisner, MD, MS | University of Pittsburgh |
More Information
No publications provided by University of Pittsburgh
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Katherine L. Wisner, MD, MS, Professor of Psychiatry, Obstetrics, Gynecology, and Reproductive Sciences, and Epidemiology, University of Pittsburgh School of Medicine; WPIC; Women's Behavioral HealthCARE |
| ClinicalTrials.gov Identifier: | NCT00744328 History of Changes |
| Other Study ID Numbers: | R01 MH057102 |
| Study First Received: | August 28, 2008 |
| Last Updated: | February 17, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Postpartum depression estradiol Postpartum major depressive disorder |
Additional relevant MeSH terms:
|
Depression, Postpartum Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Sertraline Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013