Boston, MANCT05570812Now EnrollingIRB Ready

Major Depressive Disorder Clinical Trial in Boston, MA

Access cutting-edge major depressive disorder treatment through this clinical trial at a research site in Boston. Study-provided care at no cost to qualified participants.

Sponsored by Massachusetts General Hospital

Quick Self-Assessment

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Expert Care in Boston

Access major depressive disorder specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related major depressive disorder treatment provided free

Apply for This Boston Location

Check if you qualify for this major depressive disorder clinical trial in Boston, MA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Boston

    Convenient for MA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boston site if eligible
  4. 4Begin participation

About This Major Depressive Disorder Study in Boston

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.

Sponsor: Massachusetts General Hospital

Who Can Participate

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.)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05570812) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Major Depressive Disorder Treatment Options in Boston, MA

If you're searching for major depressive disorder treatment options in Boston, MA, this clinical trial (NCT05570812) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced major depressive disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all major depressive disorder clinical trials near you to find additional studies recruiting in your area.

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