Postpartum Depression: Transdermal Estradiol Versus Sertraline - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00744328

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 IV

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:

MedlinePlus related topics: Depression Postpartum Care Postpartum Depression

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Sertraline hydrochloride Sertraline Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

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
Depressive Disorder
Depression, Postpartum
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 February 09, 2012