Tests pregnenolone pills for depressed mood in people with HIV
Compares pregnenolone with placebo in adults with HIV and depression.
Plain-language title generated from the registry record
Registry title: Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Key facts
- Where
- Boston, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT05570812, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT05570812
- Record updated
- 12 September 2025
- Original description
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.Read full original descriptionShow less
In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living With HIV
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.
Inclusion: 18-85 years; HIV-1 viral load <200 copies/mL on antiretroviral therapy (ART) at screening visit; Center for Epidemiological Studies - Depression (CES-D) score ≥ 20.
Exclusion: History of allergic reaction or side effects with prior pregnenolone use; Currently using testosterone enanthate, testosterone cypionate, or estrogen containing preparations that significantly increase systemic estrogen levels, including but not limited to oral and transdermal forms of estrogen. All other forms of exogenous sex steroid hormones will be evaluated at the discretion of the PI and/or clinical delegates; Currently using systemic immunosuppressive agents, including corticosteroids, chemotherapy, or specific immunomodulating agents, such as monoclonal antibodies and TNF-inhibitors; <70% adherence to study drug prior to randomization; Concurrent participation in another interventional trial, except for lifestyle and device studies (For vaccination studies, individuals in the observation period are not exclusionary. Other interventions will be evaluated at the discretion of the PI and/or clinical delegates.); 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); Any severe (life-threatening or unstable) medical condition as determined by clinician assessment; Severe renal disease (estimated glomerular filtration rate ≤ 30 mL/min/1.73m2); Seizure disorder requiring antiepileptic treatment; Excessive alcohol or other substances use that would interfere with classification of major depression disorder, study procedures and/or follow-up; Current diagnosis of bipolar disorder; Diagnosis of a psychotic disorder (current or lifetime); Decompensated cirrhosis, active liver inflammation (alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 5 times the upper limit of normal) or unsuppressed viral hepatitis B or C infection; Contraindication to magnetic resonance imaging (MRI) or poor-quality baseline MRI preventing image analyses as determined by radiologist assessment; 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; Blood pressure, with the lowest reading taken after three repeat readings during screening visit, ≥ 160 mmHg systolic OR ≥ 95 mmHg diastolic or other life-threatening vital signs as determined by clinician assessment; Clinically significant abnormalities in physical examination or ECG that would interfere with study participation; Diagnosis of schizophrenia (current or lifetime); Inability to swallow pills/capsules; Not able to complete neuropsychological testing in English.