Ovarian Hormones and Suicide Risk (CLEAR-2)
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|ClinicalTrials.gov Identifier: NCT03498313|
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Suicidal Ideation||Drug: Transdermal Estradiol + Placebo Drug: Oral Micronized Progesterone + Placebo Drug: Placebos||Phase 4|
Previous work from our group demonstrates that perimenstrual worsening of suicidal thoughts in females is caused by normal perimenstrual withdrawal from the ovarian steroids estradiol (E2) and progesterone (P4), since perimenstrual stabilization of E2+P4 prevented the perimenstrual worsening of suicidal ideation observed under placebo. In the present study, we follow up on that work with an additional mechanistic trial in which E2 and P4 will be stabilized in separate arms of the study.
60 (30 completers) female outpatients, with past-month suicidal ideation but minimal imminent risk for attempt, will complete self-reports and clinical interviews measuring presence and severity of suicidal ideation in each of three conditions (A, B, C: order randomized across three menstrual cycles): (A) perimenstrual E2/P4 withdrawal (under placebo), (B) perimenstrual P4 withdrawal (exogenous stabilization of E2 only), and (C) perimenstrual E2 withdrawal (exogenous stabilization of P4 only). A washout cycle will separate conditions. Analyses will compare the perimenstrual trajectories of symptoms and suicidality across the three conditions.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Crossover 3-condition placebo-controlled trial|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Ovarian Hormone Withdrawal and Suicide Risk: An Experimental Approach|
|Actual Study Start Date :||April 15, 2018|
|Estimated Primary Completion Date :||August 1, 2020|
|Estimated Study Completion Date :||August 1, 2020|
Experimental: Transdermal Estradiol + Placebo
.1mg per 24 hours transdermal estradiol applied to the skin weekly, and sugar pill manufactured to mimic the progesterone pills taken twice daily by mouth, for 14 days.
Drug: Transdermal Estradiol + Placebo
.1mg/24hr transdermal estradiol for 14 days starting day 7 after positive urine luteinizing hormone test, plus twice daily placebo pills during the same time frame.
Experimental: Oral Micronized Progesterone + Placebo
100 mg oral micronized progesterone pill taken twice daily by mouth, and clear patch manufactured to mimic the E2 patch applied to the skin weekly, for 14 days.
Drug: Oral Micronized Progesterone + Placebo
100mg oral micronized progesterone twice daily for 14 days starting day 7 after positive urine luteinizing hormone test, plus weekly application of a placebo patch during the same time frame.
Placebo Comparator: Placebos
Sugar pill designed to mimic the P4 pills taken twice daily by mouth, and clear patch manufactured to mimic the E2 patch applied to the skin weekly, for 14 days.
Twice daily placebo pills for 14 days starting day 7 after positive urine luteinizing hormone test, plus weekly application of a placebo patch during the same time frame.
- Mean Difference in Adult Suicidal Ideation Questionnaire [ Time Frame: Days 11 to 17 following positive LH test, when perimenstrual symptoms typically peak ]Within-person Difference in Mean Severity of Suicidal Ideation between each of the three conditions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498313
|Contact: Madeline Divine, BSemail@example.com|
|Contact: Shannon Dowty, MPHfirstname.lastname@example.org|
|United States, Illinois|
|University of Illinois Neuropsychiatric Institute||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Tory A Eisenlohr-Moul, PhD 859-317-0503 email@example.com|
|Principal Investigator:||Tory A Eisenlohr-Moul, PhD||University of Illinois at Chicago|