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Trial Outcomes & Findings for Study on Allopregnanolone and Depression in Perimenopausal Women (NCT NCT05329779)

NCT ID: NCT05329779

Last Updated: 2026-01-22

Results Overview

The Ruminative Responses Scale (RRS) comprises 22 items which ask how frequently the participant thinks certain statements when they feel depressed. Each item is scored from 1-4. Total scores range from 22-88 with higher scores indicating more severe rumination.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Baseline to 4 days

Results posted on

2026-01-22

Participant Flow

Participant milestones

Participant milestones
Measure
Brexanolone
Participants will receive a continuous 60-hr intravenous infusion of brexanolone brexanolone: Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
Placebo
Participants will receive a continuous 60-hr infusion of placebo placebo: The placebo is a 0.45% sodium chloride infusion.
Overall Study
STARTED
1
1
Overall Study
COMPLETED
1
1
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study on Allopregnanolone and Depression in Perimenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Brexanolone
Participants will receive a continuous 60-hr intravenous infusion of brexanolone brexanolone: Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
Placebo
Participants will receive a continuous 60-hr infusion of placebo placebo: The placebo is a 0.45% sodium chloride infusion.
Total
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Age, Categorical
>=65 years
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Sex: Female, Male
Female
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Sex: Female, Male
Male
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
White
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=270 Participants
0 Participants
n=4 Participants
0 Participants
n=9 Participants

PRIMARY outcome

Timeframe: Baseline to 4 days

Population: Results are not posted due to potential risk to confidentiality given low enrollment.

The Ruminative Responses Scale (RRS) comprises 22 items which ask how frequently the participant thinks certain statements when they feel depressed. Each item is scored from 1-4. Total scores range from 22-88 with higher scores indicating more severe rumination.

Outcome measures

Outcome data not reported

Adverse Events

Brexanolone

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Research Program Management

Brigham and Women's Hospital

Phone: 617-525-9627

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place