A Neurosteroid Intervention for Menopausal and Perimenopausal Depression

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.

Conditions

• Major Depressive Disorder
• Menopause
• Perimenopause

Interventions

DRUG

Pregnenolone

In a sequential parallel comparison design, in a double blind placebo controlled study, the efficacy of pregnenlone treatment relative to placebo in improving depression and anxiety symptoms, cognition, sleep, quality of life and vasomotor symptoms in preimenopausal and menopausal women with MDD.

DRUG

Placebo

In a sequential parallel comparison design, in a double blind placebo controlled study, the efficacy of pregnenlone treatment relative to placebo in improving depression and anxiety symptoms, cognition, sleep, quality of life and vasomotor symptoms in preimenopausal and menopausal women with MDD.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Sherwood Brown, MD, PhD · University of Texas Southwestern Medical Center

• Marlene Freeman, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

40 Years

Max Age

67 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2024-12-03

Completion

2024-12-03

FDA Drug

Yes

Countries

• United States

Study Locations