Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living With HIV
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills, Blood draws, MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants in this study will receive a pill of either pregnenolone or placebo, and can stay on their current antidepression medications."
- "Behavioral testing and blood draw will be performed at baseline, 2 weeks, 4 weeks, and 8 weeks, while magnetic resonance spectroscopy (MRS), and task-based functional magnetic resonance imaging (MRI) will be conducted at 2 weeks and 8 weeks."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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.)
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Shibani Mukerji, MD, PhD · Principal investigatorMore trials in Boston