DepressionPhase 4NCT05329779
Study on Allopregnanolone and Depression in Perimenopausal Women
A Phase 4 study testing brexanolone in people with Depression, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- brexanolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 18 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy perimenopausal women ages 40 to 60 years
- Depressive symptoms
- Able to read Arabic numerals and perform simple arithmetic
- Able to provide written informed consent
Who cannot join
- Use of medications to treat depression
- Systemic hormone therapy
- Contraindicated medications with brexanolone
- Other psychiatric illnesses that are considered to be primary
- Current suicidal ideation
- Active substance use disorders
Show all 16Show fewer
- Unstable medical conditions
- Obstructive sleep apnea or other primary sleep disorders
- Abnormal hepatic and renal function
- Known allergy to progesterone, exogenous allopregnanolone, or brexanolone
- History of head injury resulting in loss of consciousness > 20 min
- Inability to comply with barrier contraceptive methods
- Known intellectual disability
- Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition
- Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause
This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.
Read the detailed description
Midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. The investigators hypothesize that declining endogenous allopregnanolone (ALLO) levels across the menopause transition underlies perimenopausal depression. This mechanistic trial aims to amplify the contrast between lower endogenous ALLO levels in perimenopausal women and higher levels experimentally induced by exogenous ALLO. This will be achieved by using the exogenous ALLO treatment, brexanolone, which is FDA-approved to treat depression in postpartum patients, in a randomized, double-blind, parallel-arm, placebo-controlled trial. By manipulating ALLO levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in perimenopausal women.
- Conditions
- Depression
- Being tested
- brexanolone, placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brexanoloneDrug
Also called Zulresso, allopregnanolone
Brexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression.
placeboDrug
The placebo is a 0.45% sodium chloride infusion.
| Study group | Role | What they receive |
|---|---|---|
| brexanolone | Experimental | Participants will receive a continuous 60-hr intravenous infusion of brexanolone Receives: Drug: brexanolone |
| placebo | Placebo comparator | Participants will receive a continuous 60-hr infusion of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-person Change in Score on the Ruminative Responses Scale
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.
Measured: Baseline to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start4 Nov 2022
- Primary completion18 Jul 2023
- Study completion18 Jul 2023
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadine Joffe, MD MSc, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329779
- Sponsor's protocol ID
- 2021P003137
- Status last verified
- Jan 2026
- First submitted
- 8 Apr 2022
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women During the Perimenopause
- ClinicalTrials.gov ID
- NCT05329779
- Acronym / sponsor ID
- 2021P003137
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to identify how the progesterone metabolite allopregnanolone affects behavior and neurobiology that may underlie perimenopausal depression.
Detailed description
Midlife women are burdened with depression risk that is at least partly attributed to changing reproductive steroid dynamics across a prolonged reproductive transition. The investigators hypothesize that declining endogenous allopregnanolone (ALLO) levels across the menopause transition underlies perimenopausal depression. This mechanistic trial aims to amplify the contrast between lower endogenous ALLO levels in perimenopausal women and higher levels experimentally induced by exogenous ALLO. This will be achieved by using the exogenous ALLO treatment, brexanolone, which is FDA-approved to treat depression in postpartum patients, in a randomized, double-blind, parallel-arm, placebo-controlled trial. By manipulating ALLO levels together with key measurement of depression domains, this study harnesses the endocrine biology of perimenopause to explicate behavioral and neurobiological mechanisms underlying depression in perimenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brexanolone | Experimental | Drug: brexanoloneParticipants will receive a continuous 60-hr intravenous infusion of brexanolone |
| placebo | Placebo comparator | Drug: placeboParticipants will receive a continuous 60-hr infusion of placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy perimenopausal women ages 40 to 60 years
- Depressive symptoms
- Able to read Arabic numerals and perform simple arithmetic
- Able to provide written informed consent
Key exclusion criteria (16 listed)
- Use of medications to treat depression
- Systemic hormone therapy
- Contraindicated medications with brexanolone
- Other psychiatric illnesses that are considered to be primary
- Current suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brexanoloneAlso: Zulresso, allopregnanoloneBrexanolone is a derivative of allopregnanolone, which is FDA-approved to treat postpartum depression. | Drug | brexanolone |
| placeboThe placebo is a 0.45% sodium chloride infusion. | Drug | placebo |
Primary outcome
Within-person Change in Score on the Ruminative Responses Scale
Time frame: Baseline to 4 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing brexanolone in people with Depression, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-person Change in Score on the Ruminative Responses Scale (time frame: Baseline to 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.