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NCT04112368 · ClinicalTrials.gov registry record · Phase 4
Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach
A Phase 4 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 4
- Development phase
- 124
- Enrollment target
NCT04112368: Completed Phase 4 study, sponsored by University of Illinois at Chicago.
NCT04112368 is a Phase 4 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 124 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04112368, a Phase 4 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 124 participants
- Enrollment target
Study Summary
Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cyclical changes in hormones and their metabolites influence short-term risk of suicide. The data acquired will contribute to our understanding of the biology of acute suicide risk and advance efforts to develop safe and effective treatments that eliminate predictable monthly worsening of suicide risk in reproductive-age females.
Primary Outcome
The Adult Suicidal Ideation Questionnaire (ASIQ) is a 25-item self-report questionnaire assessing suicidality. Each day, individuals rate each of 25 items on a scale from 1 (Not at All) to 6 (Extreme). Mean scores are computed, providing a single number for each day that represents the participant's mean suicidal ideation (1 to 6), with higher daily values representing more severe suicidal ideation. Perimenstrual change scores are calculated for each person in each condition as the mean of scor
Interventions
- DRUG Placebo capsule
- DRUG Estradiol Transdermal Patch 0.1 mg/24 hrs
- DRUG Oral Micronized Progesterone 200mg
- DRUG Inactive Clear Patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2020-09-15 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 4 |
What the finished NCT04112368 record still lists
NCT04112368 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo capsule is the first listed.
NCT04112368 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04112368 about?
NCT04112368 is a clinical study titled "Cyclical Neuroactive Steroid Changes, Arousal, and Proximal Suicide Risk: An Experimental Approach". Female suicide attempts occur more often in the weeks before and after menses onset, and have been linked to ovarian hormone withdrawal. The proposed project will use a two-week intervention to stabilize hormones in females with recent suicidal thoughts; this paradigm is a safe way to learn how cycl...
What is the current status of trial NCT04112368?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 124 participants. The study started on 2020-09-15. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT04112368?
The interventions under investigation include: Placebo capsule (DRUG), Estradiol Transdermal Patch 0.1 mg/24 hrs (DRUG), Oral Micronized Progesterone 200mg (DRUG), Inactive Clear Patch (DRUG).
Who is sponsoring clinical trial NCT04112368?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04112368's enrollment target sits among peer trials
124 656th of 2000 higher than 1,339 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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