Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMassachusetts General Hospital
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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, incarcerated)
Use of cobicistat or ritonavir
Trial design
Treatments tested in this trial
- Placebo
- Pregnenolone
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Institute for Medical Research, Inc.
Collaborator
Source ClinicalTrials.gov