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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 is a Phase 4 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 124 participants.

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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.

Interventions

  • DRUG Placebo capsule
  • DRUG Estradiol Transdermal Patch 0.1 mg/24 hrs
  • DRUG Oral Micronized Progesterone 200mg
  • DRUG Inactive Clear Patch

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2020-09-15
Est. Completion 2024-08-01
Phase Phase 4

Sponsor

University of Illinois at Chicago

430 total trials

What the Registry Record Tells You About NCT04112368

The ClinicalTrials.gov registry entry for NCT04112368 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo capsule is the first listed.

NCT04112368 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.