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

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effects of pregnenolone on brain function, inflammation and depressive symptoms in people living 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Institute for Medical Research, Inc.; National Institute of Mental Health (NIMH)
• Treatments: Neurosteroids

Criteria

Inclusion Criteria:

• 18-70 years

• HIV-1 viral load <200 copies/mL on antiretroviral therapy

• Center for Epidemiological Studies - Depression (CES-D) score ≥ 20

Exclusion Criteria:

• Contraindication to magnetic resonance imaging

• 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 repeat testing during screening visit, ≥ 140 mmHg systolic OR ≥ 90 mmHg diastolic or other life-threatening vital signs as determined by clinician assessment

• Clinically significant abnormalities in physical examination or ECG

• Cirrhosis or active liver inflammation (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 5 times the upper limit of normal) or untreated viral hepatitis diagnosis of alcohol use disorder

• Severe renal disease (estimated glomerular filtration rate ≥ 30 mL/min/1.73m2)

• Seizure disorder requiring antiepileptic treatment

• History of allergic reaction or side effects with prior pregnenolone use

• Currently using hormone replacement therapy

• Currently using immunomodulators (e.g. corticosteroids, tumor necrosis factor (TNF) -inhibitors)

• Excessive alcohol or other substances use that would interfere with study procedures and/or follow-up

• Diagnosis of bipolar disorder (current or lifetime)

• Diagnosis of a psychotic disorder (current or lifetime)

• Diagnosis of schizophrenia (current or lifetime)

• Inability to swallow pills/capsules

• Not able to complete neuropsychological testing in English