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Neurosteroid

Pregnenolone for Menopausal Depression

Phase 1 & 2
Recruiting
Led By Marlene Freeman, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women who are using hormonal IUDs (i.e. brands Mirena and Skyla), with FSH level > 20 mIU/m
Women aged 40-67 years who are perimenopausal or early postmenopausal
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights

Study Summary

This trial is testing if the drug pregnenolone can help reduce depressive symptoms in women with Major Depressive Disorder.

Who is the study for?
Women aged 40-62 experiencing menopause or early postmenopausal symptoms, with significant hot flashes and diagnosed major depressive disorder. They must not be using certain medications or supplements for menopause and depression, have uncontrolled health conditions, or a history of hormone-sensitive tumors.Check my eligibility
What is being tested?
The trial is testing if Pregnenolone can better reduce depression in perimenopausal women compared to a placebo. It also looks at effects on anxiety, cognition, quality of life, and vasomotor symptoms. The study measures changes in neurosteroid levels to understand the treatment's mechanism.See study design
What are the potential side effects?
While specific side effects are not listed here, pregnenolone may cause hormonal changes that could affect mood and physical well-being. Participants will be monitored for any adverse reactions throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use a hormonal IUD and my FSH level is over 20.
Select...
I am a woman aged 40-67 and am going through or have just finished menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome measures
Greene Climacteric Scale (GCS)
Hamilton Anxiety Rating Scale (HRSA)
Menopause Specific Quality of Life (MEN-QOL)
+3 more
Other outcome measures
Blood drawn
Cognitive and Physical Functioning Questionnaire (CPFQ)
Columbia-Suicide Severity Rating Scale (C-SSRS)
+1 more

Side effects data

From 2011 Phase 4 trial • 80 Patients • NCT01409096
3%
Sinusitis
3%
Corneal ulceration
3%
Skin abscess followed by allergic reaction to antibiotic used to treat it
3%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Pregnenolone

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Pregnenlone (phase 1 and 2)Experimental Treatment1 Intervention
Participants will receive pregnenolone at phase 1 (baseline-WK 7) and 2 (WK 8-16). The titration schedule is as follows: at baseline a 50 mg (BID, 7 days). WK 1=150 mg (BID, 7 days); WK 2=250 mg (BID, 14 days) and WK 4=250 mg (BID, 14 days) (BID, 14 days). At phase 2 (WK 8) to maintain the double blind of rerandomization, treatment in all conditions recommence at a dosage frequency similar to phase 1. At WK 8=250 mg (BID, 7 days); at WK 9=250 mg (BID, 7 days); WK 10=250 mg (BID, 14 days) and WK 12=250 mg (BID, 14 days) . During the participants' final WK (16), they will be instructed to titrate down the treatment according to the following schedule: 150 mg (BID, 4 days) and 50 mg (BID, 4 days), discontinue.
Group II: Placebo rerandom to pregnenoloneExperimental Treatment2 Interventions
Participants will receive placebo at phase 1 (baseline-WK 7) & treatment response assessed (MADRS score reduced <50% at WK8). Nonresponders are rerandomized to receive either treatment at phase 2 (WK8-16).The titration schedule is as follows (dosage throughout is BID): at baseline placebo (7 days). At WK 1=placebo (7 days); WK 2=placebo (14 days) & WK 4=placebo (14 days). Placebo nonresponders who are rerandomized to pregnenolone: At WK 8=250 mg (7 days);WK 9=250 mg (7 days);WK 10=250 mg (14 days) & WK 12=250 mg (14 days). During the participants' final WK (16), they will be instructed to titrate down the treatment according to the following schedule: 150 mg (4 days) and 50 mg (4 days), discontinue.
Group III: Placebo rerandom to placeboPlacebo Group1 Intervention
Participants will receive placebo at phase 1 (baseline-WK 7) & treatment response assessed (MADRS score reduced <50% at WK8). Nonresponders are rerandomized to receive either treatment at phase 2 (WK8-16).The titration schedule is as follows (dosage throughout is BID): at baseline placebo (7 days). At WK 1= placebo (7 days); at WK 2=placebo (14 days) and WK 4=placebo (14 days). Placebo nonresponders rerandomized to placebo: At WK 8=placebo (7 days);WK 9=placebo (7 days);WK 10=placebo (14 days) and WK 12=placebo (14 days). During the participants' final WK (16), they will be instructed to titrate down (done in order to maintain the double blind) the treatment according to the following schedule: placebo (4 days) and placebo (4 days), discontinue.
Group IV: Placebo responsive cont placeboPlacebo Group1 Intervention
Participants will placebo throughout phase 1 (baseline- WK 7) & treatment response assessed (MADRS score reduced <50% at WK8). Responders continue to receive placebo at phase 2 (WK8-16).The titration schedule is as follows (dosage throughout is BID): at baseline placebo (7 days). At WK 1=placebo (7 days); WK 2=placebo (14 days) & WK 4=placebo (14 days). Placebo responders remain on placebo: At WK 8, placebo (7 days); WK 9=placebo (7 days); WK 10=placebo (14 days) & WK 12=placebo (14 days). During the participants' final WK (16), they will be instructed to titrate down (done in order to maintain the double blind) the treatment according to the following schedule: placebo= 4 days) and placebo=4 days, discontinue.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pregnenolone
2011
Completed Phase 4
~770
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,055 Previous Clinical Trials
1,054,765 Total Patients Enrolled
47 Trials studying Depression
19,401 Patients Enrolled for Depression
Massachusetts General HospitalOTHER
2,946 Previous Clinical Trials
13,204,480 Total Patients Enrolled
187 Trials studying Depression
32,369 Patients Enrolled for Depression
Marlene Freeman, MDPrincipal InvestigatorMassachusetts General Hospital
2 Previous Clinical Trials
55 Total Patients Enrolled
2 Trials studying Depression
55 Patients Enrolled for Depression

Media Library

Pregnenolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03505905 — Phase 1 & 2
Depression Research Study Groups: Pregnenlone (phase 1 and 2), Placebo rerandom to placebo, Placebo responsive cont placebo, Placebo rerandom to pregnenolone
Depression Clinical Trial 2023: Pregnenolone Highlights & Side Effects. Trial Name: NCT03505905 — Phase 1 & 2
Pregnenolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03505905 — Phase 1 & 2
~13 spots leftby Jan 2025
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