Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610305
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Ovarian Hormone Withdrawal Anhedonia and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ovarian Hormone Withdrawal Anhedonia and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression A Crossover Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEAR
Brief 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
--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
Detailed Description:
Potential participants will first be screened over the phone to assess health history including mental health and reproductive status Those who meet inclusionexclusion criteria will be invited to an in-person enrollment session 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
Following enrollment women will complete daily mood ratings for one menstrual cycle using EMA this is called the 34prospective-assessment34 phase Those who meet our predetermined mood criteria during prospective assessment will move into a one-cycle lead-in phase of the study where they will continue daily EMA for those who do not study participation will conclude Participants will complete a single in-person visit during the lead-in phase at which they will be randomized to one of two conditions within the randomized crossover design they will also complete an acute stress task and computer tasks while EEG is recorded
During the intervention phase the first condition will receive transdermal estradiol E2 01mgdoral progesterone P4 200mgd during the luteal phase of cycle 1 of the intervention phase third cycle overall and placebo transdermaloral during the luteal phase of cycle 3 of the intervention phase fifth cycle overall the second will receive placebo during the luteal phase of intervention cycle 1 and transdermal E2oral P4 during the luteal phase of intervention cycle 3 Cycle 2 will be a washout for both conditions mood assessment only without hormone collection or labs 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 Women will also complete two lab sessions tied to the mid-follicular and late luteal phases as determined by a fixed time window relative to ovulation At each lab session EEG will be recorded during computer tasks that probe reward sensitivity responses from which will serve as our primary outcome measure
Following enrollment women will complete daily mood ratings for one menstrual cycle using EMA this is called the 34prospective-assessment34 phase Those who meet our predetermined mood criteria during prospective assessment will move into a one-cycle lead-in phase of the study where they will continue daily EMA for those who do not study participation will conclude Participants will complete a single in-person visit during the lead-in phase at which they will be randomized to one of two conditions within the randomized crossover design they will also complete an acute stress task and computer tasks while EEG is recorded
During the intervention phase the first condition will receive transdermal estradiol E2 01mgdoral progesterone P4 200mgd during the luteal phase of cycle 1 of the intervention phase third cycle overall and placebo transdermaloral during the luteal phase of cycle 3 of the intervention phase fifth cycle overall the second will receive placebo during the luteal phase of intervention cycle 1 and transdermal E2oral P4 during the luteal phase of intervention cycle 3 Cycle 2 will be a washout for both conditions mood assessment only without hormone collection or labs 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 Women will also complete two lab sessions tied to the mid-follicular and late luteal phases as determined by a fixed time window relative to ovulation At each lab session EEG will be recorded during computer tasks that probe reward sensitivity responses from which will serve as our primary outcome measure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None