Phase 4
N=30
Effect of Perimenstrual Ovarian Steroid Supplementation on Perimenstrual Suicidality
Suicidal Ideation
Bottom Line
View on ClinicalTrials.gov: NCT03720847 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Ideation Score — -.05; .35 units on a scale — p=.012
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Estradiol Transdermal Patch 0.1 mg/24 hrs (Drug); Oral Micronized Progesterone (Drug); Inactive Clear Patch (Drug); Placebo capsule (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Ideation Score |
-.05; .35 | .012 sig |
| PRIMARY Perimenstrual Change in Self-Injurious Thoughts and Behaviors Interview (SITBI) Suicidal Planning Score |
-.06; .17 | .030 sig |
| SECONDARY Perimenstrual Change in Beck Hopelessness Scale (BHS) Score |
-.017; 1.37 | .013 sig |
| SECONDARY Perimenstrual Change in Center for Epidemiological Studies Depression Scale (CES-D) Score |
-1.53; 2.69 | .018 sig |
| SECONDARY Perimenstrual Change in Lack of Premeditation Subscale Score of the "Urgency, Premeditation, Perseverance, Sensation Seeking, and Positive Urgency (UPPSP) Impulsivity Scale" |
-.75; .27 | .073 |
| SECONDARY Perimenstrual Changes in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Anxiety Scale Score |
1.39; .17 | .25 |
| SECONDARY Perimenstrual Change in State Self-Esteem Scale Social Evaluation Subscale (SSES-SE) Score |
1.65; -.33 | .23 |
Summary
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03720847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.