In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living With HIV
Massachusetts General Hospital
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.
Description
Pregnenolone is a neuroactive steroid that exhibits actions highly relevant to treating depression in people with HIV. The investigators' recent human data suggest that neuroactive steroids are decreased in people with HIV and depression. In addition, multiple groups have reported reductions in neuroactive steroids in people without HIV who have depression. A total of 120 people living with HIV on antiretroviral therapy with depression will be randomized to either pregnenolone or placebo (2 groups/90 participants receiving pregnenolone and 30 participants receiving placebo). Drug dosage will b…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Contraindication to magnetic resonance imaging (MRI) or poor-quality baseline MRI preventing image analyses as determined by radiologist assessment * Recent severe infections including opportunistic infections, active bacterial, mycobacterial, fungal, or certain viral infections * Vulnerable populations (e.g., pregnant/nursing, severe cognitive or intellectual impairment, incarcerate…
Interventions
- DrugPlacebo
(4-week ramp, 4-week steady dosing)
- DrugPregnenolone
(4-week ramp, 4-week steady dosing)
Location
- Massachusetts General HospitalBoston, Massachusetts