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Neurosteroid

Brexanolone for Depression in Perimenopausal Women

Phase 4

Recruiting

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of depressive symptoms

Healthy perimenopausal women ages 40 to 60 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 days

Awards & highlights

Study Summary

This trialexamines the link between a hormone and depression symptoms in menopause, to better understand and treat the condition.

Who is the study for?

This trial is for healthy perimenopausal women aged 40 to 60 who are experiencing depressive symptoms. Participants must be able to understand basic math and give informed consent. They cannot have sleep disorders, be on hormone therapy or certain medications, have severe psychiatric illnesses other than depression, unstable health conditions, liver/kidney issues, allergies to progesterone-related compounds, significant head injuries, intellectual disabilities or substance use disorders.Check my eligibility

What is being tested?

The study is testing the effects of a progesterone metabolite called allopregnanolone (given as brexanolone) versus a placebo in managing depression during perimenopause. It aims to understand how this compound influences behavior and brain function related to depression at this stage of life.See study design

What are the potential side effects?

Brexanolone may cause dizziness, sleepiness, sudden changes in mood or behavior including agitation or aggression; it can also potentially lead to allergic reactions in those sensitive to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am experiencing symptoms of depression.

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I am a healthy woman aged 40 to 60, going through perimenopause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Within-person change in score on the Ruminative Responses Scale

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: brexanoloneExperimental Treatment1 Intervention

Participants will receive a continuous 60-hr intravenous infusion of brexanolone

Group II: placeboPlacebo Group1 Intervention

Participants will receive a continuous 60-hr infusion of placebo

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,615 Previous Clinical Trials

11,470,750 Total Patients Enrolled

28 Trials studying Depression

115,873 Patients Enrolled for Depression

Media Library

Brexanolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05329779 — Phase 4

Depression Research Study Groups: brexanolone, placebo

Depression Clinical Trial 2023: Brexanolone Highlights & Side Effects. Trial Name: NCT05329779 — Phase 4

Brexanolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05329779 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research program accepting elderly participants aged 85 or older?

"This clinical trial is recruiting participants aged between 40 and 60 years old."

Answered by AI

How perilous is brexanolone for individuals with treatment?

"Based on its Phase 4 status, brexanolone is deemed to be a safe treatment option with a score of 3."

Answered by AI

To what extent has enrollment been successful for this research endeavor?

"Yes, clinicaltrials.gov's data verifies that enrollment for this trial is still open. The listing was initially published on November 4th 2022 and has been updated most recently on the 8th of the same month. 80 participants are needed from a single medical site."

Answered by AI

Is enrollment for this clinical trial currently open?

"Affirmative. According to information on clinicaltrials.gov, this clinical trial is seeking volunteers and was first posted on November 4th 2022 with the last update occurring November 8th of the same year. 80 individuals are needed at one medical centre for participation in this study."

Answered by AI

Who is eligible to partake in this research initiative?

"This research project is recruiting eighty participants aged between 40 and 60, who suffer from depression. In addition to these requirements, potential candidates must be literate in Arabic numerals and possess basic arithmetic skills; they have to be healthy perimenopausal women with the capacity of offering informed consent via writing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study on Allopregnanolone and Depression in Perimenopausal Women

Hadine Joffe, MD MSc 2022. "Study on Allopregnanolone and Depression in Perimenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05329779.

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