NCT05570812 Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
| NCT ID | NCT05570812 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-03-03 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-03-03 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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, 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 * 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.)
Contact & Investigator
Shibani S. Mukerji, MD, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05570812 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05570812 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05570812 currently recruiting?
Yes, NCT05570812 is actively recruiting participants. Contact the research team at MGHSOOTHE@PARTNERS.ORG for enrollment information.
Where is the NCT05570812 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05570812 clinical trial?
NCT05570812 is sponsored by Massachusetts General Hospital. The principal investigator is Shibani S. Mukerji, MD, PhD at Massachusetts General Hospital. The trial plans to enroll 120 participants.