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Neurosteroid

Pregnenolone for Menopausal Depression

Phase 1 & 2

Recruiting

Led By Sherwood Brown, MD, PhD

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

Must not have

Treatment resistant depression

Acute psychiatric disorder other than MDD that is the primary focus of symptom burden or treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

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.

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.

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

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I use a hormonal IUD and my FSH level is over 20.

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I am a woman aged 40-67 and am going through or have just finished menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My depression has not improved with treatment.

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My main mental health issue is not major depressive disorder.

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I haven't taken certain medications in the last 2 weeks.

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My high blood pressure is not under control.

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My family or I have a history of hormone-sensitive tumors.

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I have received hormone therapy for my reproductive organs within the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary study objectives

Greene Climacteric Scale (GCS)

Hamilton Anxiety Rating Scale (HRSA)

Menopause Specific Quality of Life (MEN-QOL)

+3 more

Other study objectives

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

Sinusitis

Corneal ulceration

Skin abscess followed by allergic reaction to antibiotic used to treat it

Skin rash

100%

80%

60%

40%

20%

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