RecruitingMajor Depressive DisorderAnxiety DepressionHIV
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Eligible age
18–85 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
- ✕ High risk for suicide (active suicidal ideation (SI) with plan/intent as assessed by using the Columbia Suicide Severity Rating (C-SSRS) or \> 2 attempts in lifetime or any in the past 6 months) or expresses homicidal ideation necessitating clinical intervention or representing an imminent concern
- ✕ Any severe (life-threatening or unstable) medical condition as determined by clinician assessment
- ✕ Blood pressure, with the lowest reading taken after three repeat readings during screening visit, ≥ 160 mmHg systolic OR ≥ 95 mmHg diastolic or other life-threatening vital signs as determined by clinician assessment
- ✕ Clinically significant abnormalities in physical examination or ECG that would interfere with study participation
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT05570812 · last updated 2025-09-12