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New treatment option for Major Depressive Disorder
Official title Neuroactive Steroid to Treat Depressed Mood: A Trial for People With HIV
ClinicalTrials.gov ID: NCT05570812
What this study is testing
What is Pregnenolone?
Pregnenolone is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for major depressive disorder.
Also referred to as Neuroactive steroid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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
You likely can't join if
- 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...
- Any severe (life-threatening or unstable) medical condition as determined by clinician assessment
See the full eligibility 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
- 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...
- 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...
- 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 treatment 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 study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.