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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Oct 6, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the effects of a medication called pregnenolone on mood and brain function in people with HIV who are also experiencing depression. The goal is to see if pregnenolone can help improve symptoms of depression and reduce inflammation in the brain. Participants will take either pregnenolone or a placebo (a pill with no active ingredients) while continuing their current antidepressant medications. Throughout the study, researchers will conduct brain imaging and behavioral tests to gather more information.

To be eligible for this trial, participants must be between 18 and 85 years old, have an HIV-1 viral load of less than 200 copies/mL while on antiretroviral therapy, and show signs of depression based on a specific scoring system. However, certain conditions, such as severe infections, high blood pressure, or a history of serious mental health issues, may exclude someone from participating. Those who join the study can expect regular check-ins and assessments to monitor their health and wellbeing during the trial. This study is currently recruiting participants, and all genders are welcome to apply.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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
• • 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
• • Any severe (life-threatening or unstable) medical condition as determined by clinician assessment
• • 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
• • 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
• • Severe renal disease (estimated glomerular filtration rate ≤ 30 mL/min/1.73m2)
• • Seizure disorder requiring antiepileptic treatment
• • History of allergic reaction or side effects with prior pregnenolone use
• • Currently using testosterone enanthate, testosterone cypionate, and specific preparations containing estrogen. 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
• • 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)
• • Diagnosis of schizophrenia (current or lifetime)
• • \<70% adherence to study drug prior to randomization
• • Inability to swallow pills/capsules
• • Not able to complete neuropsychological testing in English
• • 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.)