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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 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.

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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

Conditions Studied

Major Depressive Disorder

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

FieldValue
Enrollment Target 75 participants
Start Date 2024-09-02
Est. Completion 2028-06-01
Phase Phase 4

Sponsor

University of North Carolina, Chapel Hill

1,109 total trials

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What the Registry Record Tells You About NCT06610305

The ClinicalTrials.gov registry entry for NCT06610305 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (80% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.