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RecruitingPhase 4

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

Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression: A Crossover Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills, Urine samples, Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
  • "At enrollment, consent will be obtained and participants will complete a structured interview and a series of questionnaires."
  • "Interested participants will be educated on the use of smartphone-based ecological momentary assessment (EMA) surveys, which will be used to complete daily mood ratings over the course of the study."
  • "During cycles 1 and 3, every-other-day urine samples will be collected for estradiol and progesterone metabolites and daily anhedonia symptoms will be assessed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how hormone changes affect mood, pleasure, and brain responses to rewards in women ages 18–45 whose depression gets worse before their period. It tests whether estrogen patches and progesterone pills help by keeping these hormones from dropping before a period. Participants receive both hormones and a placebo (no active medicine) at different times.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female at birth and ages 18–45.
  • Report regular periods every 25–35 days.
  • Have a past diagnosis of major depression and report that symptoms get worse before periods.
  • If you have children, it has been at least 1 year since giving birth.
  • Speak English.

Who can't join

  • Pregnant, breastfeeding, or trying to get pregnant. Participants must use barrier birth control, such as condoms, during the study.
  • Using hormone medicines or an IUD (a birth control device in the uterus). Past hormone use must have stopped at least 1 month before the study, with one normal period before joining.
  • Body mass index (BMI), a measure based on height and weight, below 18 or above 29.
  • A long-term illness that could affect the study, such as diabetes, cancer, seizures, endometriosis, heart or organ disease, migraine with aura, high blood pressure, Parkinson’s disease, ongoing pain, or blood clots.
  • Family history that suggests a higher risk of breast cancer or blood clot disorders.
  • Currently smoke cigarettes.
  • A history of mania (extreme high mood or energy), psychosis (trouble knowing what is real), or a drug or alcohol use disorder.
  • Active thoughts of suicide in the past 12 months or a suicide attempt in the past 5 years.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause). * Self-reported regular menstrual cycles between 25 and 35 days. * A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms. * If the woman has children, she must be at least 1 year postpartum. * English-speaking Exclusion Criteria: * Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again at the first visit of the second condition. Women will be instructed to use a barrier method of birth control during the study. * Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women who were previously taking oral contraceptives or other hormonal medications must have one normal menstrual cycle (menstrual period) prior to enrollment in the study. * BMI less than 18 or greater than 29. * A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, pulmonary disease, migraine with aura, hypertension, Parkinson's disease, chronic pain, and thromboembolic events. * A family history indicative of increased risk of breast cancer or thromboembolic disorders. * Current cigarette smoking. * A history of mania, psychosis, or substance use disorder. * Any recent history (last 12 months) of active suicidal ideation, or suicide attempt within the last 5 years.

Study sites (1)

NC