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New treatment option for Depression
Official title Examining the Effects of Estradiol on Neural and Molecular Response to Reward
ClinicalTrials.gov ID: NCT05282277
What this study is testing
What is Transdermal Estradiol?
Transdermal Estradiol is an investigational medicine, being studied as a potential treatment for depression.
Also referred to as Climara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This proposal will examine the effects of estradiol administration on perimenopausal-onset (PO) anhedonia and psychosis symptoms as well as on brain function using simultaneous positron emission tomography and functional magnetic resonance imaging (PET-MR).
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 55, women only
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
- 44-55 years old unmedicated perimenopausal women who have ≥ 2 skipped menstrual cycles, amenorrhea ≥ 60 days, corresponding to the late menopause...
- Anhedonia or psychosis symptoms that began during the period of menstrual irregularity.
- Clinician's Global Impression Scale-Severity score (CGI-S) \> 3 to confirm a clinically impaired sample.
You likely can't join if
- Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®.
- BMI \ 35 kg/m\^2
- A history of chronic menstrual cycle irregularity, meaning \> 1 year without menses
- MR contraindications: Metal in the body, dental work other than fillings or gold, tattoos, metal injury, any other implant unless they are 100%...
- PET contradictions: participation in \>1 research study in the past 12 months that included ionizing radiation exceeding 3 rem to the whole body...
- The use of psychotropics or hormonal preparations.
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures, lifestyle considerations, and availability for the duration of the study
- 44-55 years old unmedicated perimenopausal women who have ≥ 2 skipped menstrual cycles, amenorrhea ≥ 60 days, corresponding to the late menopause transition (Stages of Reproductive Aging Workshop (STRAW stage -1).
- Anhedonia or psychosis symptoms that began during the period of menstrual irregularity.
- Clinician's Global Impression Scale-Severity score (CGI-S) \> 3 to confirm a clinically impaired sample.
- Anhedonia severity and stratification: All participants will have Snaith-Hamilton Pleasure Scale (SHAPS) scores \> 20 consistent with the NIMH Fast-Fail Trial for Mood and Anxiety Disorders, corresponding to clinically...
- Psychosis severity and stratification: Participants will be stratified according to scores on the psychotic subscale of the Brief Psychiatric Rating Scale (BPRS)
- Willingness to adhere to the estradiol regimen
- Pregnancy; allergies to any active or inactive ingredients in the Climara® patch or Prometrium®.
- BMI \ 35 kg/m\^2
- A history of chronic menstrual cycle irregularity, meaning \> 1 year without menses
- MR contraindications: Metal in the body, dental work other than fillings or gold, tattoos, metal injury, any other implant unless they are 100% plastic.
- PET contradictions: participation in \>1 research study in the past 12 months that included ionizing radiation exceeding 3 rem to the whole body (e.g., PET, CT). Standard of care imaging is not exclusionary.
- The use of psychotropics or hormonal preparations.
- History of psychiatric illness during the 2 years before the onset of perimenopause.
- History of chronic, recurrent mood or psychotic disorders (i.e., more than one non-reproductive-related mood episode prior to the perimenopausal index episode).
- A history of mood episodes requiring hospitalization.
- Current mania;
- Depressive episode(s) within 2 years of enrollment not associated with the transition to menopause;
- A history of suicide attempts within the last year or current active suicidal ideation with intent and plan.
- Neurological conditions (e.g., history of seizure or TBI)
- Brain stimulation treatment in the past six months.
- Endometriosis;
- First degree relative with premenopausal breast cancer or breast cancer presenting in both breasts or multiple family members (greater than three relatives) with postmenopausal breast cancer.
- Current medication use (i.e., current psychotropics, current anti-hypertensives, current statins, current hormonal preparations, or frequent use of anti-inflammatory agents (\> 10 times/month)). Women will be allowed to...
- Pregnant, breastfeeding or trying to conceive;
- Last menstrual period more than 12 months prior to enrollment;
- History of undiagnosed vaginal bleeding;
- Undiagnosed enlargement of the ovaries;
- Polycystic ovary syndrome;
- History of breast or ovarian cancer;
- First degree relative with ovarian cancer;
- Abnormal finding in a provider breast exam and/or mammogram;
- Known carrier of BRCA1 or 2 mutation;
- Porphyria;
- Malignant melanoma;
- Hodgkin's disease;
- Recurrent migraine headaches that are preceded by aura;
- Gallbladder or pancreatic disease\ \ ;
- Heart or kidney disease\ \ ;
- Liver disease;
- cerebrovascular disease (stroke);
- First degree relative with history of heart attack or stroke;
- Current nicotine use;
- Self-reported claustrophobia
- Peanut allergy
- all reported prescription medications will be reviewed and cleared by a study physician prior to a participant's enrollment;
- participants will be given the opportunity to describe these conditions in the online screening survey. Reported conditions that are acute in nature and/or benign will be reviewed by a study physician and exclusions...
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 45 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.