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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE April 15, 2018
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03498313 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ovarian Hormones and Suicide Risk
Official Title  ICMJE Ovarian Hormone Withdrawal and Suicide Risk: An Experimental Approach
Brief Summary This within-person, crossover, 3-condition, placebo-controlled study compares the impact of three perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The three conditions are (1) perimenstrual withdrawal from estradiol only (during progesterone stabilization), (2) perimenstrual withdrawal from progesterone only (during estradiol stabilization), and (3) perimenstrual withdrawal from both estradiol and progesterone during placebo.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover 3-condition placebo-controlled trial
Masking: Double (Participant, Investigator)
Masking Description:
double-blind
Primary Purpose: Basic Science
Condition  ICMJE Suicidal Ideation
Intervention  ICMJE
  • 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.
    Other Names:
    • Climara
    • sugar pill
  • 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.
    Other Names:
    • Prometrium
    • placebo patch
  • Drug: Placebos
    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.
    Other Names:
    • sugar pill
    • placebo patch
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Transdermal Estradiol + Placebo
  • 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.
    Intervention: Drug: Oral Micronized Progesterone + Placebo
  • 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.
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Must not test positive for opioid use, cocaine use, or methamphetamine use at the enrollment visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Madeline Divine, BS 314-315-3848 mdivine@uic.edu
Contact: Shannon Dowty, MPH 312-355-5652 sdowty@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498313
Other Study ID Numbers  ICMJE IRB # 2018-0189
R00MH109667 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Illinois at Chicago
Study Sponsor  ICMJE University of Illinois at Chicago
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Tory A Eisenlohr-Moul, PhD University of Illinois at Chicago
PRS Account University of Illinois at Chicago
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP