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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06610305
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Transdermal estradiol — DRUG
    0.1 mg/day delivered via weekly patch
  • Progesterone — DRUG
    100 mg twice daily (200 mg/day total) administered via oral capsule
  • Transdermal placebo patch — DRUG
    Once weekly via transdermal patch
  • placebo capsule — DRUG
    Twice daily via oral capsule

Study Details

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

Key Dates

Start date
Sep 2, 2024
Status verified
Oct 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Estradiol+Progesterone, then Placebo
    Two weeks of luteal phase transdermal estradiol (0.1mg/day)+oral progesterone (200 mg/day) during the first intervention cycle, followed by a one cycle washout, followed by two weeks of luteal phase transdermal/oral placebo
  • Experimental: Placebo, then Estradiol+Progesterone
    Two weeks of luteal phase transdermal/oral placebo during the first intervention cycle, followed by a one cycle washout, followed by two weeks of luteal phase transdermal estradiol (0.1 mg/day)+oral progesterone (200 mg/day)

Primary Outcome Measure

Dimensional Anhedonia Rating Scale (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase) [ Time Frame: 3 menstrual cycles (each cycle approximately 28 days in duration) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina, Chapel HillChapel HillNorth Carolina27707
Study Coordinator
[email protected]
(919) 445-6814

Find similar trials in Chapel Hill, NC

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
University of North Carolina, Chapel Hill· Chapel Hill, NC

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