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

NCT05570812 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-09-12

No results posted yet for this study

Summary

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

Interventions

DRUG

Placebo

(4-week ramp, 4-week steady dosing)

DRUG

Pregnenolone

(4-week ramp, 4-week steady dosing)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Institute for Medical Research, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Shibani S. Mukerji, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2027-06-30
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05570812 on ClinicalTrials.gov