Postpartum Depression: Transdermal Estradiol Versus Sertraline

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial of Estrogen for Postpartum Depression

NCT00059228

Postpartum Depression Depression

TERMINATED PHASE2

Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

NCT02235064

Depression, Postpartum

TERMINATED NA

Maternal Mental Health Trial

NCT04685148

Major Depressive Disorder Postpartum Depression

RECRUITING PHASE1/PHASE2

Sertraline for the Prevention of Recurrent Postpartum Depression

NCT00276900

Depression

COMPLETED PHASE3

A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression

NCT02122393

Depression Anxiety

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Transdermal Estradiol

Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The capsules for women in this arm do not contain any active ingredients. The skin patch contains transdermal estradiol ranging in dose from 50 to 200 mcg/day

Group Type EXPERIMENTAL

Transdermal Estradiol

Intervention Type DRUG

Estradiol patch ranging in dose from 50 to 200 mcg/day

Placebo

Intervention Type OTHER

Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Sertraline

Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The skin patch contains no active ingredients, though packaging is designed to match active patches. The capsules contain sertraline ranging in dose from 25 to 200mg/day

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

Sertraline dose will range from 50 - 200 mg/day

Placebo

Intervention Type OTHER

Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Placebo

Women wear a skin patch that is changed weekly and take opaque capsules by mouth daily. The capsules for women in this arm do not contain any active ingredients. The skin patch contains no active ingredients, though packaging is designed to match active patches.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transdermal Estradiol

Estradiol patch ranging in dose from 50 to 200 mcg/day

Intervention Type DRUG

Sertraline

Sertraline dose will range from 50 - 200 mg/day

Intervention Type DRUG

Placebo

Placebo patches and pills that are identical to transdermal estradiol and oral sertraline, respectively, will be used.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Vivelle dot Climara Zoloft

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 18-45 years
* Had a baby within the last 3 months
* Experiencing depression or lasting sadness

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 (unless willing to cut down)
* personal history of thromboembolic event, hypercoagulability, or first degree relatives with thromboembolic events.
* Current or past personal history of breast, uterine, or ovarian cancer.
* BRCA-positive mother
* 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.
* Diabetes
* Pregnancy
* Infants born \<32 weeks of gestation
* Imminent suicidality and/or homicidality: in need of higher level of care than is provided in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Katherine Wisner

Norman and Helen Asher Professor of Psychiatry and Behavioral Sciences and Obstetrics and Gynecology; Director, Asher Center for the Study and Treatment of Depressive Disorders

Responsibility Role PRINCIPAL_INVESTIGATOR