Study on Allopregnanolone and Depression in Perimenopausal Women

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05329779
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • brexanolone — DRUG
    Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
  • placebo — DRUG
    The placebo is a 0.45% sodium chloride infusion.

Study Details

This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.

Key Dates

Start date
Nov 4, 2022
Status verified
Jan 2026
Primary completion
Jul 18, 2023
Completion
Jul 18, 2023

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: brexanolone
    Participants will receive a continuous 60-hr intravenous infusion of brexanolone
  • Placebo Comparator: placebo
    Participants will receive a continuous 60-hr infusion of placebo

Primary Outcome Measure

Within-person Change in Score on the Ruminative Responses Scale [ Time Frame: Baseline to 4 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Related coverage on Hipa.ai

Find similar trials in Boston, MA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Brigham and Women's Hospital· Boston, MA

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