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Trial record 2 of 66 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Illinois, United States ) | NIH, U.S. Fed

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

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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Drug: Transdermal Estradiol + Placebo Drug: Oral Micronized Progesterone + Placebo Drug: Placebos Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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


Arm Intervention/treatment
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.
Other Names:
  • Climara
  • sugar pill

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.
Other Names:
  • Prometrium
  • placebo patch

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.
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Madeline Divine, BS 314-315-3848 mdivine@uic.edu
Contact: Shannon Dowty, MPH 312-355-5652 sdowty@uic.edu

Locations
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United States, Illinois
University of Illinois Neuropsychiatric Institute Recruiting
Chicago, Illinois, United States, 60612
Contact: Tory A Eisenlohr-Moul, PhD    859-317-0503    temo@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Tory A Eisenlohr-Moul, PhD University of Illinois at Chicago

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Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03498313     History of Changes
Other Study ID Numbers: IRB # 2018-0189
R00MH109667 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by University of Illinois at Chicago:
steroid hormones
estradiol
estrogen
progesterone
depression
suicide

Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms
Hormones
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogens
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins