Postpartum Depression: Transdermal Estradiol Versus Sertraline

NCT00744328 | Terminated Phase 4 Results DMC

• 1 other identifier: R01MH057102
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Depression

Keywords

Postpartum depression; estradiol; Postpartum major depressive disorder

Outcome Measures

Primary Outcomes (1)

• To Test the Efficacy of Estradiol for the Treatment of Postpartum Depression - Percent Change in SIGH-ADS29

  Depression was assessed with the Structured Interview Guide for the Hamilton Depression Rating Scale - Atypical Depression Symptoms Version (SIGH-ADS29). The scale incorporates the 17 and 21-item Hamilton Rating Scales for Depression (HRSD) as well as 8 atypical symptoms of depression. Scores range from 0 to 90, where a higher score corresponds to a higher level of depressive symptomatology.

  Week 8

Secondary Outcomes (1)

• Infant Serum Concentrations of Estradiol in 3 Treatment Arms

  monthly

Study Arms (3)

Transdermal Estradiol

EXPERIMENTAL

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

Drug: Transdermal Estradiol; Other: Placebo

Sertraline

ACTIVE COMPARATOR

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

Drug: Sertraline; Other: Placebo

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Transdermal Estradiol DRUG

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

Also known as: Vivelle dot, Climara

Transdermal Estradiol

Sertraline DRUG

Sertraline dose will range from 50 - 200 mg/day

Also known as: Zoloft

Sertraline

Placebo OTHER

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

Placebo; Sertraline; Transdermal Estradiol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine; Asher Center for the Study and Treatment of Depressive Disorders

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

• Pulido CM, Walson IS, Yang A, Stika CS, Sit DK, Wisner KL. Differentiating Depressive Symptoms From Side Effects in Individuals With Major Depressive Disorder With Postpartum Onset. J Clin Psychopharmacol. 2025 Mar-Apr 01;45(2):106-110. doi: 10.1097/JCP.0000000000001928. Epub 2024 Dec 4.

  PMID: 39626074 DERIVED

• Prairie BA, Wisniewski SR, Luther JF, Sit D, Wisner KL. Postpartum lipid levels in women with major depression. J Womens Health (Larchmt). 2012 May;21(5):534-8. doi: 10.1089/jwh.2011.3256. Epub 2012 Jan 27.

  PMID: 22283499 DERIVED

Related Links

• Northwestern Psychiatry Homepage

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Estradiol; Sertraline

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Research Study Coordinator
• Organization: Northwestern University

emily.pinheiro@northwestern.edu

312-695-8441

Study Officials

• Katherine L Wisner, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 10, 2019
• Results First Posted: October 23, 2014

Record last verified: 2018-08

Locations

US (1)