Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV

Recruiting Phase 2 Interventional Study
Major Depressive Disorder Anxiety Depression HIV
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Massachusetts General Hospital · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 prev…
Contacts

Hemi Park, MPH

857-282-3788

MGHSOOTHE@PARTNERS.ORG

CONTACT

Shibani S. Mukerji, MD, PhD

857-282-9950

SMUKERJI@MGB.ORG

CONTACT