Actively Recruiting
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Led by Massachusetts General Hospital · Updated on 2025-09-12
120
Participants Needed
1
Research Sites
256 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- HIV-1 viral load less than 200 copies/mL on antiretroviral therapy at screening
- Center for Epidemiological Studies - Depression (CES-D) score of 20 or higher
You will not qualify if you...
- Contraindication to MRI or poor-quality baseline MRI preventing analysis
- Recent severe infections including opportunistic, bacterial, mycobacterial, fungal, or certain viral infections
- Vulnerable populations such as pregnant or nursing individuals, those with severe cognitive or intellectual impairment, or incarcerated persons
- Use of cobicistat or ritonavir
- High risk for suicide or homicidal ideation requiring clinical intervention
- Severe or unstable medical conditions as assessed by clinicians
- Blood pressure readings of 160 mmHg systolic or higher, or 95 mmHg diastolic or higher
- Clinically significant abnormalities in physical exam or ECG interfering with participation
- Decompensated cirrhosis, active liver inflammation, or unsuppressed viral hepatitis B or C
- Severe renal disease with estimated glomerular filtration rate 30 mL/min/1.73m2 or lower
- Seizure disorder requiring antiepileptic treatment
- History of allergic reaction or side effects to pregnenolone
- Current use of testosterone enanthate, testosterone cypionate, or estrogen preparations that significantly increase systemic estrogen levels
- Use of systemic immunosuppressive agents including corticosteroids, chemotherapy, monoclonal antibodies, or TNF-inhibitors
- Excessive alcohol or substance use interfering with depression diagnosis or study procedures
- Current diagnosis of bipolar disorder, psychotic disorder, or schizophrenia
- Less than 70% adherence to study drug before randomization
- Inability to swallow pills or capsules
- Inability to complete neuropsychological testing in English
- Concurrent participation in another interventional trial except lifestyle or device studies
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
H
Hemi Park, MPH
CONTACT
S
Shibani S. Mukerji, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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