- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04112368
Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach (CLEAR-3)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Tory A Eisenlohr-Moul, Ph.D.
- Phone Number: 859-317-0503
- Email: temo@uic.edu
Study Contact Backup
- Name: Sekine Ozturk, B.A.
- Phone Number: (312) 355-2659
- Email: sozturk2@uic.edu
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois Neuropsychiatric Institute
-
Contact:
- Tory A Eisenlohr-Moul, Ph.D.
- Phone Number: 859-317-0503
- Email: temo@uic.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ability to adhere to medication regimen
- Speaks English
- Assigned female at birth with intact ovaries
- Premenopausal
- Normal menstrual cycles between 25-35 days
- Under current care of an outpatient mental health provider with visits occurring at least once every 3 months.
- At least 1 year postpartum.
- Willing to use a barrier method of birth control during the study.
- Normal weight (BMI between 18-29)
- Must report at least some recent suicidal ideation (in the past month) at the time of recruitment.
- Must be categorized as having acceptably low imminent risk for suicidal crisis/attempt by a licensed clinical psychologist utilizing evidence-based clinical and research guidelines for imminent suicide risk management.
Exclusion Criteria:
- Must not be pregnant, breastfeeding, or trying to become pregnant.
- Must not be taking any form of exogenous hormones or hormonal intrauterine device, and must have ended previous use of hormonal preparations at least one month prior to the study.
- Must not have a personal history of any chronic medical condition, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, or pulmonary disease, and no personal or first degree family history of thromboembolic events.
- Any current cigarette smoking is exclusionary.
- Must not report a history of clinical diagnosis or treatment for postpartum depression or premenstrual dysphoric disorder (Note: Premenstrual Dysphoric - - - Disorder diagnosis must have been made based on prospective daily ratings).
- Must not report any history of manic episode, any history of psychotic symptoms, or current substance use disorder.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active condition, then Inactive condition
Beginning 7 days after ovulation, active treatment begins 7 days after ovulation with an estradiol transdermal patch (0.1 mg/24 hrs) applied to the skin weekly (spanning 14 days of treatment) along with (active) 100 mg oral micronized progesterone capsules taken twice daily by mouth for 14 days.
A 1-month washout is observed.
Then, beginning 7 days after ovulation, inactive placebo capsules will be taken twice daily by mouth along with the application of inactive clear patches applied to the skin weekly for 14 days.
|
Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
Other Names:
100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation (200mg total per day)
Other Names:
Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
Other Names:
Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
Other Names:
|
Placebo Comparator: Inactive condition, then active condition
Beginning 7 days after ovulation, inactive placebo capsules will be taken twice daily by mouth along with the application of inactive clear patches applied to the skin weekly for 14 days.
After completing a 1-month washout, active treatment begins 7 days after ovulation with an (active) estradiol transdermal patch applied to the skin weekly (spanning 14 days of treatment) along with (active) 100 mg oral micronized progesterone capsules taken twice daily by mouth for 14 days.
|
Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
Other Names:
100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation (200mg total per day)
Other Names:
Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
Other Names:
Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perimenstrual Change in Daily Adult Suicidal Ideation Questionnaire (ASIQ) Scores
Time Frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
The Adult Suicidal Ideation Questionnaire (ASIQ) is a 25-item self-report questionnaire assessing suicidality. Each day, individuals rate each of 25 items on a scale from 1 (Not at All) to 6 (Extreme). Mean scores are computed, providing a single number for each day that represents the participant's mean suicidal ideation (1 to 6), with higher daily values representing more severe suicidal ideation. Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in suicidal ideation, and negative values represent a perimenstrual decrease. |
Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
Perimenstrual Change in Daily Columbia Suicide Severity Rating Scale (C-SSRS) Screening Interview Planning Item Scores
Time Frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
The Columbia Suicide Severity Rating Scale is an interview designed to assess various aspects of suicide risk. In the present study, this questionnaire is administered daily via phone interview as part of a risk screening process. Here, we utilize a single dichotomous outcome from a single item representing suicidal planning from the C-SSRS interview: "Today, have you thought about how or when you might kill yourself?". Each day, individuals chose either "Yes" (coded as 1) or "No" (coded as 0). Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in suicidal planning, and negative values represent a perimenstrual decrease. |
Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perimenstrual Change in Daily Beck Hopelessness Scale (BHS) Short Form Scores
Time Frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
Hopelessness is assessed with a daily Beck Hopelessness Scale (short form), a 10-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 10. Scores provide a measure of the severity of self-reported hopelessness, with higher scores representing greater hopelessness. Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in hopelessness, and negative values represent a perimenstrual decrease. |
Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
Perimenstrual Change in Daily Brief Agitation Measure (BAM) Scores
Time Frame: Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
Agitation is assessed with a daily Brief Agitation Measure (BAM), a 3-item self-report measure in which participants rate their symptoms of agitation ranging from 0 (Strongly Disagree) to 6 (Strongly Agree). Mean daily scores (ranging from 0 to 6) provide a measure of the severity of self-reported agitation, with higher scores representing greater agitation. Perimenstrual change scores are calculated for each person in each condition as the mean of scores in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean in the midluteal phase (days +0 to +5). Therefore, positive values represent a perimenstrual increase in agitation, and negative values represent a perimenstrual decrease. |
Mean daily rating in the perimenstrual phase (days +12 to +17 following a positive luteinizing hormone surge in urine on day=0) minus the mean daily rating in the midluteal phase (days +0 to +5)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tory A Eisenlohr-Moul, Ph.D, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0624
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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