Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMassachusetts General Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Contraindication to magnetic resonance imaging (MRI) or poor-quality baseline MRI preventing image analyses as determined by radiologist assessment
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)
Use of cobicistat or ritonavir
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo
Drug(4-week ramp, 4-week steady dosing)
Pregnenolone
Drug(4-week ramp, 4-week steady dosing)
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: PlaceboExperimental treatment 1 intervention
Group B: PregnenoloneExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gamma-aminobutyric acid (GABA) Concentration
Comparison between Pregnenolone and Placebo Groups of Left Insular Cortex GABA Concentration, Adjusted for Baseline.
Time frame
Day 14, Day 56Secondary outcomes
1
Center for Epidemiological Studies-Depression (CES-D; scores range from 0 (no symptoms) to 60 (maximum severity of depressive symptoms))
Comparison of Percentage of Pregnenolone and Placebo Groups Showing Clinical Improvement of Depression at Study End. The revised CES-D is administered, and the total score is calculated by adding the responses to the 20 questions.
Time frame
Day 0, Day 14, Day 562
CD14+CD16+ Monocytes
Comparison of the Percentage of CD14+CD16+ Monocytes Over Time Adjusted for Baseline Between Pregnenolone and Placebo Groups
Time frame
Day 0, Day 14, Day 28, Day 563
GABA Concentration in Responders
Comparison of Baseline Left Insular Cortex GABA and Pregnenolone Between Participants in Pregnenolone Group with Clinical Improvement Compared to Clinical Non-Improvers in Pregnenolone Group
Time frame
Day 0, Day 14, Day 564
Adverse Events
Comparison of the Incidence and Severity of Adverse Events Between Pregnenolone and Placebo Groups
Time frame
Day 14, Day 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Institute for Medical Research, Inc.
Collaborator
Source ClinicalTrials.gov