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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05570812
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    (4-week ramp, 4-week steady dosing)
  • Pregnenolone — DRUG
    (4-week ramp, 4-week steady dosing)

Study Details

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.

Key Dates

Start date
Mar 3, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo
    Participants will be on the following dosage schedule: 50 mg daily for 2 weeks, THEN 100 mg daily for 1 week, THEN 250 mg daily for 1 week, THEN 500 mg daily for 4 weeks
  • Experimental: Pregnenolone
    Participants will be on the following dosage schedule: 50 mg daily for 2 weeks, THEN 100 mg daily for 1 week, THEN 250 mg daily for 1 week, THEN 500 mg daily for 4 weeks

Primary Outcome Measure

Gamma-aminobutyric acid (GABA) Concentration [ Time Frame: Day 14, Day 56 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Shibani Mukerji, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
HIVDepression
By specialty
Infectious diseasePsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MA

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