Study on Allopregnanolone and Depression in Women Across the Menopause Transition
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorBeth Israel Deaconess Medical Center
About this trial
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy women ages 40 to 60 years in the menopause transition
Depressive symptoms
Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
Able to read Arabic numerals and perform simple arithmetic
Disqualifiers
Systemic hormone therapy
Contraindicated medications with pregnenolone
Systemic corticosteroid
Other psychiatric illnesses that are considered to be primary
Trial design
Design model
Parallel
Treatments tested in this trial
pregnenolone
Dietary supplementPregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.
placebo
Other interventionPlacebo pills are identical-appearing capsules containing cellulose
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: pregnenoloneExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Within-person change in score on the Ruminative Responses Scale
The Ruminative Responses Scale (RRS) comprises 22 items which ask how frequently the participant thinks certain statements when they feel depressed. Each item is scored from 1-4. Total scores range from 22-88 with higher scores indicating more severe rumination.
Time frame
Baseline to 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov