In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living With HIV
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people with HIV who have depression. Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications. Brain imaging and behavioral assessments will be performed during the study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 18-85 years
• HIV-1 viral load \<200 copies/mL on antiretroviral therapy (ART) at screening visit
• Center for Epidemiological Studies - Depression (CES-D) score ≥ 20
Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Hemi Park, MPH
MGHSOOTHE@PARTNERS.ORG
857-282-3788
Backup
Shibani S. Mukerji, MD, PhD
SMUKERJI@MGB.ORG
857-282-9950
Time Frame
Start Date: 2023-03-03
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 120
Treatments
Experimental: Placebo
Participants will be on the following dosage schedule:~50 mg daily for 2 weeks, THEN 100 mg daily for 1 week, THEN 250 mg daily for 1 week, THEN 500 mg daily for 4 weeks
Experimental: Pregnenolone
Participants will be on the following dosage schedule:~50 mg daily for 2 weeks, THEN 100 mg daily for 1 week, THEN 250 mg daily for 1 week, THEN 500 mg daily for 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: National Institute of Mental Health (NIMH), Institute for Medical Research, Inc.