RecruitingPhase 2NCT05570812

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

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

Sponsor

Massachusetts General Hospital

Enrollment

120 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

Anxiety Depression Major Depressive Disorder HIV

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a medication called a neuroactive steroid to help with depressed mood in people living with HIV whose virus is well-controlled. Researchers believe this drug may improve mood and brain function in this group. **You may be eligible if...** - You are between 18 and 85 years old - You are living with HIV and your viral load is below 200 copies/mL on antiretroviral therapy - You score 20 or higher on a standard depression questionnaire (CES-D) **You may NOT be eligible if...** - You have a medical reason you cannot have an MRI scan - You have a recent serious infection - You are pregnant, nursing, or have severe cognitive impairment - You are taking certain HIV drugs (cobicistat or ritonavir) - You have a high risk of suicide Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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