Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-11-30

Brief Summary

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This within-person, crossover, 2-condition, placebo-controlled study compares the impact of two perimenstrual conditions on severity of suicidal symptoms in females with past-month suicidality but minimal risk of imminent suicide attempt. The two conditions are (1) natural perimenstrual withdrawal from estradiol and progesterone (during placebo), (2) perimenstrual stabilization of estradiol and progesterone using transdermal estradiol and oral micronized progesterone.

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Detailed Description

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A large number of observational studies have documented increased risk of suicide attempt, suicide death, and more lethal attempts during the perimenstrual (around menses) window of the female reproductive cycle; however, no experiments have investigated the causal role of ovarian steroid changes across the natural perimenstrual period in risk factors for acute suicidality. In response, the proposed experimental work investigates a causal role of perimenstrual withdrawal from the hormones estradiol (E2) and progesterone (P4) in previously-documented acute perimenstrual increases in suicidality.

Participants are 30 women between the ages of 18 and 45 with current suicidal ideation but minimal risk for suicide attempt. Using a placebo-controlled, crossover within-person design, the experiment tests the hypothesis that suicidality will be heightened during natural perimenstrual E2/P4 withdrawal (under placebo), but that experimental prevention of this perimenstrual E2/P4 withdrawal (with exogenous administration of E2/P4 hormones) will prevent these perimenstrual increases in suicidality and associated risk factors.

Conditions

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Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover 2-Condition Placebo-Controlled Trial

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Identical placebos provided by the UNC investigational drug service.

Study Groups

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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.

Group Type EXPERIMENTAL

Estradiol Transdermal Patch 0.1 mg/24 hrs

Intervention Type DRUG

Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation

Oral Micronized Progesterone

Intervention Type DRUG

100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation

Inactive Clear Patch

Intervention Type DRUG

Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation

Placebo capsule

Intervention Type DRUG

Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation

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.

Group Type PLACEBO_COMPARATOR

Estradiol Transdermal Patch 0.1 mg/24 hrs

Intervention Type DRUG

Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation

Oral Micronized Progesterone

Intervention Type DRUG

100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation

Inactive Clear Patch

Intervention Type DRUG

Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation

Placebo capsule

Intervention Type DRUG

Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation

Interventions

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Estradiol Transdermal Patch 0.1 mg/24 hrs

Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation

Intervention Type DRUG

Oral Micronized Progesterone

100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation

Intervention Type DRUG

Inactive Clear Patch

Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation

Intervention Type DRUG

Placebo capsule

Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation

Intervention Type DRUG

Other Intervention Names

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Climara Prometrium Placebo transdermal patch Sugar pill

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No