Pregnenolone as an add-on treatment for depression in people living with HIV

In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living with HIV.

NIH-funded research Massachusetts General Hospital · NIH-11132975

Adults living with HIV and depression will receive pregnenolone or a placebo in addition to their usual care to try to improve mood while researchers measure brain and immune changes.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionMassachusetts General Hospital NIH-funded
Lab location1 site (Boston, United States)
Project IDNIH-11132975 on NIH RePORTER

What this research studies

You would join a randomized, double-blind trial where 120 adults with HIV and depression are assigned in a 3:1 ratio to receive pregnenolone or a placebo for eight weeks as an add-on to their current treatment. The study includes regular mood assessments and blood tests to track immune signals. You will have MRI scans, including magnetic resonance spectroscopy and task-based functional MRI, to look at brain GABA activity and responses. The team will compare changes in mood with changes in brain chemistry and peripheral inflammation to understand who benefits.

Who could benefit from this research

Good fit: Adults living with HIV who are on antiretroviral therapy and currently experiencing depressive symptoms, and who can undergo MRI scans, are the ideal candidates.

Not a fit: People without HIV, those not experiencing depression, pregnant individuals, or anyone with contraindications to MRI or pregnenolone may not benefit from participation.

Why it matters

Potential benefit: If successful, this could offer a new add-on therapy to reduce depressive symptoms and related brain/immune changes in people living with HIV.

How similar studies have performed: Neuroactive steroids like pregnenolone have shown benefits for mood and pain in other psychiatric studies, but this approach is relatively new for depression specifically in people living with HIV.

Where this research is happening

Boston, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions Acquired Immune Deficiency Syndrome VirusAcquired Immunodeficiency Syndrome VirusAffective Disorders
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.