A Neurosteroid Intervention for Menopausal and Perimenopausal Depression
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.