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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
Must not have
Use of medications to treat depression
Abnormal hepatic and renal function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 4 days
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medication for depression.
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My liver and kidney functions are not normal.
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I am currently on hormone therapy.
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I have a medical condition that changes rapidly.
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I have been diagnosed with obstructive sleep apnea or another sleep disorder.
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I am not taking any medications that should not be used with brexanolone.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Within-person change in score on the Ruminative Responses Scale

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,670 Previous Clinical Trials
11,878,186 Total Patients Enrolled
29 Trials studying Depression
115,895 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
~30 spots leftby Apr 2026
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