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NCT06610305 · ClinicalTrials.gov registry record · Phase 4
Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
A Phase 4 study of Major Depressive Disorder, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT06610305: Recruiting Phase 4 study of Major Depressive Disorder, sponsored by University of North Carolina, Chapel Hill.
NCT06610305 is a Phase 4 study of Major Depressive Disorder that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 75 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06610305, a Phase 4 study of Major Depressive Disorder, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Measures several domains of hedonic function, including desire, motivation, effort, and consummatory pleasure, across various contexts. 17 items, max score 68, higher scores indicate greater anhedonia.
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Transdermal estradiol
- DRUG Transdermal placebo patch
- DRUG placebo capsule
Study Locations (1)
North Carolina
- University of North Carolina, Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2024-09-02 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 4 |
What NCT06610305 shows while recruiting
NCT06610305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 4 interventions - of which Progesterone is the first listed.
NCT06610305 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06610305 about?
NCT06610305 is a clinical study titled "Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression". 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...
What is the current status of trial NCT06610305?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2024-09-02. Estimated completion is 2028-06-01.
What conditions does trial NCT06610305 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06610305?
The interventions under investigation include: Progesterone (DRUG), Transdermal estradiol (DRUG), Transdermal placebo patch (DRUG), placebo capsule (DRUG).
Who is sponsoring clinical trial NCT06610305?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06610305 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06610305's enrollment target sits among peer trials
75 150th of 282 higher than 131 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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