CompletedPhase 1/2

A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

United States73 participantsStarted 2018-09-01

Plain-language summary

HYPOTHESIS: Pregnenolone administration will be associated with greater reduction in depressive symptom severity than placebo in women with current mMDD. STUDY AIMS: Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive symptom severity than placebo in women with mMDD, as measured by MADRS. Secondary Aims: 1. Determine if pregnenolone is associated with greater reduction in anxiety symptom severity than placebo in women with mMDD. 2. Determine if pregnenolone is associated with greater improvement in cognition than placebo in women with mMDD. 3. Determine if pregnenolone is associated with greater improvement in quality of life than placebo in women with mMDD. 4. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms of menopause than placebo. Mechanistic Aims: 1. Determine whether changes in neurosteroid levels with pregnenolone mediate clinical response. 2. Determine if baseline neurosteroid levels predict pregnenolone response. 3. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve first. A crossed-lagged panel model will explore serial correlations between changes in outcome measures.

Who can participate

Age range

40 Years – 67 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: The participants must meet the following criteria: * Women aged 40-67 years who are perimenopausal or early postmenopausal (within 5 years of the last menstrual period if not surgically postmenopausal), including: * Women who have experienced changes in menstrual cycle frequency or duration, and/or physical symptoms indicative of menopausal transition, as determined by clinician * Women who are using hormonal IUDs (i.e. brands Mirena and Skyla), with FSH level \> 20 mIU/m (as menstrual periods are irregular with IUDs that utilize hormones, making irregular/absent periods difficult to assess as related to the menopausal transition). * Women with significant menopause-related physical symptoms, indicated by any of the following criteria: * Greene Climacteric Scale total scores \> 20 * Greene Climacteric Scale sub-score for vasomotor symptoms \>3 * 5 or more bothersome hot flashes per week (self-reported) * Women meeting DSM-5 criteria for current major depressive disorder (assessed by the SCID) * Baseline HRSD score of ≥ 18 * Subject agrees to abstain from disallowed medications for the duration of the trial Exclusion Criteria: The participants must not meet any of the following criteria: * Vulnerable populations (e.g. pregnant/nursing, severe cognitive or intellectual impairment, incarcerated) * Pregnancy (determined by urine pregnancy test), intending pregnancy or breast feeding * Psychiatric disorder other than MDD that is acute and the primary focus…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Montgomery-Asberg Depression Rating Scale (MADRS)

Timeframe: Phase 1 timeframe is Baseline to Week 8; Phase 2 timeframe is Week 8 to Week 16

Trial details

NCT IDNCT03505905

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-03

Results submitted2025-11-26

View on ClinicalTrials.gov More Major Depressive Disorder trials