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Hormone Therapy

Estradiol 2 Mg tablet for Postpartum Depression

Phase 2
Waitlist Available
Led By Crystal E Schiller, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks
Awards & highlights

Study Summary

This trial will look at the effects of hormones on irritability in women, specifically examining whether those who are sensitive to hormones show different responses than those who are not.

Eligible Conditions
  • Postpartum Depression
  • Depression

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean BOLD Activation of the Left Amygdala During the Affective Posner Task Over Time
Mean BOLD Activation of the Left Caudate During the Affective Posner Task Over Time
Mean BOLD Activation of the Left Nucleus Accumbens During the Affective Posner Task Over Time
+9 more
Secondary outcome measures
Correlation Between Irritability Subcortical Activation in HS+ During Hormone Addback
Correlation Between Irritability and Reactive Aggression During Hormone Addback
Correlation Between the Inventory of Depressive and Anxiety Symptoms (IDAS) Ill -0.8Scale and Threat Attention Bias
+2 more

Side effects data

From 2022 Phase 2 trial • 23 Patients • NCT04051320
69%
Hot flashes
62%
Fatigue
54%
Headache
46%
Spotting
46%
Dizziness
31%
Irritability
31%
Emotional sensitivity
23%
Anxiety
23%
Bloating
23%
Arm soreness (Lupron IM injection)
23%
Gastrointestinal upset
23%
Weight gain
15%
Depressed mood
15%
General musculoskeletal pain
15%
Early insomnia
15%
Low back pain
15%
Cramps
15%
Migraine
15%
Anhedonia
8%
Occular migraine
8%
Fever (COVID-19 infection)
8%
Anosmia (COVID-19 infection)
8%
Dry cough (Seasonal allergies)
8%
Mood swings
8%
Intrusive thoughts
8%
Concussion
8%
Breast tenderness
8%
Decreased appetite
8%
Difficulty concentrating
8%
Hormonal acne
8%
COVID-19 Infection
8%
Low libido
8%
Insomnia
8%
Heartburn
8%
Hematoma (IM injection)
8%
Yeast infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormone Sensitive Women (HS+)
Hormone Insensitive Women (HS-)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Hormone Sensitive Women (HS+)Experimental Treatment3 Interventions
Participants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks.
Group II: Hormone Insensitive Women (HS-)Experimental Treatment3 Interventions
Participants will take leuprolide acetate (lupron) via intramuscular injection, for 2 months. Participants will take 2 mg of estradiol twice daily and 200 mg of progesterone twice daily for 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Micronized progesterone
2020
Completed Phase 4
~1580
Estradiol 2 Mg tablet
2020
Completed Phase 2
~30
Leuprolide Acetate 3.75 MG/ML
2020
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,191,019 Total Patients Enrolled
5 Trials studying Postpartum Depression
317 Patients Enrolled for Postpartum Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,676 Total Patients Enrolled
24 Trials studying Postpartum Depression
8,120 Patients Enrolled for Postpartum Depression
Crystal E Schiller, PhDPrincipal InvestigatorUNC Dept of Psychiatry
2 Previous Clinical Trials
123 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Trends in Cognitive SciencesJournal
Pediatric Irritability: A Systems Neuroscience Approach
Leibenluft, Ellen. 2017. “Pediatric Irritability: A Systems Neuroscience Approach”. Trends in Cognitive Sciences. Elsevier BV. doi:10.1016/j.tics.2017.02.002.
American Journal of PsychiatryJournal
Familiality of Postpartum Depression in Unipolar Disorder: Results of a Family Study
Forty, Liz, B.A., Lisa Jones Ph.D., Stuart Macgregor Ph.D., Sian Caesar, Caroline Cooper B.Sc., Andrea Hough B.A., Laura Dean B.Sc., M.S, et al.. 2006. “Familiality of Postpartum Depression in Unipolar Disorder: Results of a Family Study”. American Journal of Psychiatry. American Psychiatric Association Publishing. doi:10.1176/ajp.2006.163.9.1549.
Psychological AssessmentJournal
Development and Validation of the Inventory of Depression and Anxiety Symptoms (IDAS).
Watson, David, Michael W. O'Hara, Leonard J. Simms, Roman Kotov, Michael Chmielewski, Elizabeth A. McDade-Montez, Wakiza Gamez, and Scott Stuart. 2007. “Development and Validation of the Inventory of Depression and Anxiety Symptoms (IDAS).”. Psychological Assessment. American Psychological Association (APA). doi:10.1037/1040-3590.19.3.253.
NeuroImageJournal
Neural Reward Processing Is Modulated by Approach- and Avoidance-related Personality Traits
Simon, Joe J., Stephan Walther, Christian J. Fiebach, Hans-Christoph Friederich, Christoph Stippich, Matthias Weisbrod, and Stefan Kaiser. 2010. “Neural Reward Processing Is Modulated by Approach- and Avoidance-related Personality Traits”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2009.09.016.
~4 spots leftby Apr 2025
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