DepressionSADIE-PNCT06238700
Study on Allopregnanolone and Depression in Women Across the Menopause Transition
A study testing pregnenolone in people with Depression, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) 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?
- pregnenolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 women ages 40 to 60 years in the menopause transition
- Depressive symptoms
- Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
- Able to read Arabic numerals and perform simple arithmetic
- Able to provide written informed consent
Who cannot join
- Systemic hormone therapy
- Contraindicated medications with pregnenolone
- Systemic corticosteroid
- 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 pregnenolone
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Aleta Wiley
About this study
Official title: Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) 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. We 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 induced by pregnenolone. This will be achieved by using the over-the-counter dietary supplement, pregnenolone, 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 women across the menopause transition.
- Conditions
- Depression
- Being tested
- pregnenolone, placebo
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregnenoloneDietary supplement
Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
placeboOther
Placebo pills are identical-appearing capsules containing cellulose
| Study group | Role | What they receive |
|---|---|---|
| pregnenolone | Experimental | Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks Receives: Dietary Supplement: pregnenolone |
| placebo | Placebo comparator | Participants will take placebo twice per day for four weeks Receives: Other: 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 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 May 2026
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadine Joffe, Beth Israel Deaconess Medical Center
- Investigators
- Katherine Burdick, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238700
- Sponsor's protocol ID
- 2026P000017
- Acronym
- SADIE-P
- Status last verified
- Aug 2026
- First submitted
- 26 Jan 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition
- ClinicalTrials.gov ID
- NCT06238700
- Acronym / sponsor ID
- SADIE-P / 2026P000017
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
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 enhanced allopregnanolone activity (via pregnenolone) 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. We 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 induced by pregnenolone. This will be achieved by using the over-the-counter dietary supplement, pregnenolone, 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 women across the menopause transition.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnenolone | Experimental | Dietary Supplement: pregnenoloneParticipants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks |
| placebo | Placebo comparator | Other: placeboParticipants will take placebo twice per day for four weeks |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy women ages 40 to 60 years in the menopause transition
- Depressive symptoms
- Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
- Able to read Arabic numerals and perform simple arithmetic
- Able to provide written informed consent
Key exclusion criteria (16 listed)
- Systemic hormone therapy
- Contraindicated medications with pregnenolone
- Systemic corticosteroid
- 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 |
|---|---|---|
| pregnenolonePregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement. | Dietary supplement | pregnenolone |
| placeboPlacebo pills are identical-appearing capsules containing cellulose | Other | placebo |
Primary outcome
Within-person change in score on the Ruminative Responses Scale
Time frame: Baseline to 2 weeks
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- 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.
Katherine Burdick, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pregnenolone in people with Depression, run by Beth Israel Deaconess Medical Center 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 5 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: looking for participants now, as of the sponsor's last update on 26 Aug 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleta Wiley, MPH (617-975-8706, awiley3@bidmc.harvard.edu), or a site near the patient. 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 2 weeks). 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 26 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.