Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression

Summary

The goal of this clinical trial is to learn how hormonal changes over the menstrual cycle affect mood symptoms in reproductive-aged women with depression that worsens during the premenstrual period. The main questions it aims to answer are:

--How do fluctuations in estradiol and progesterone across the menstrual cycle affect the ability to experience pleasure and the neural sensitivity to reward in hormone-sensitive, depressed women? And consequently, how does stabilizing the luteal phase decline in estrogen and progesterone (using estradiol patches and progesterone pills) affect these changes?

Participants will:

* Receive hormones followed by placebo, or vice versa, for a total of four weeks across three menstrual cycles
* Complete daily mood ratings
* Collect home urine samples for hormone testing
* Complete five biobehavioral testing sessions during which neural responses are recorded (via electroencephalography, or EEG) during an acute stress task and computer tasks

Conditions

• Major Depressive Disorder

Interventions

DRUG

Transdermal estradiol

0.1 mg/day delivered via weekly patch

DRUG

Progesterone

100 mg twice daily (200 mg/day total) administered via oral capsule

DRUG

Transdermal placebo patch

Once weekly via transdermal patch

DRUG

placebo capsule

Twice daily via oral capsule

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Chris Sikes-Keilp, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-02

Primary Completion

2028-06-01

Completion

2028-06-01

FDA Drug

Yes

Countries

• United States

Study Locations