RECRUITING

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

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Conditions

Major Depressive DisorderAnxiety DepressionHIVDepressionNeuroactive SteroidPregnenolone

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

In Vivo Targeting of Neuroactive Steroid and Immune Networks for Depression in People Living With HIV

Quick Facts

Study Start:2023-03-03
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05570812

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-85 years
  2. * HIV-1 viral load \<200 copies/mL on antiretroviral therapy (ART) at screening visit
  3. * Center for Epidemiological Studies - Depression (CES-D) score ≥ 20
  1. * Contraindication to magnetic resonance imaging (MRI) or poor-quality baseline MRI preventing image analyses as determined by radiologist assessment
  2. * Recent severe infections including opportunistic infections, active bacterial, mycobacterial, fungal, or certain viral infections
  3. * Vulnerable populations (e.g., pregnant/nursing, severe cognitive or intellectual impairment, incarcerated)
  4. * Use of cobicistat or ritonavir
  5. * 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
  6. * Any severe (life-threatening or unstable) medical condition as determined by clinician assessment
  7. * 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
  8. * Clinically significant abnormalities in physical examination or ECG that would interfere with study participation
  9. * 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
  10. * Severe renal disease (estimated glomerular filtration rate ≤ 30 mL/min/1.73m2)
  11. * Seizure disorder requiring antiepileptic treatment
  12. * History of allergic reaction or side effects with prior pregnenolone use
  13. * 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.
  14. * Currently using systemic immunosuppressive agents, including corticosteroids, chemotherapy, or specific immunomodulating agents, such as monoclonal antibodies and TNF-inhibitors
  15. * Excessive alcohol or other substances use that would interfere with classification of major depression disorder, study procedures and/or follow-up
  16. * Current diagnosis of bipolar disorder
  17. * Diagnosis of a psychotic disorder (current or lifetime)
  18. * Diagnosis of schizophrenia (current or lifetime)
  19. * \<70% adherence to study drug prior to randomization
  20. * Inability to swallow pills/capsules
  21. * Not able to complete neuropsychological testing in English
  22. * 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.)

Contacts and Locations

Study Contact

Hemi Park, MPH
CONTACT
857-282-3788
MGHSOOTHE@PARTNERS.ORG
Shibani S. Mukerji, MD, PhD
CONTACT
857-282-9950
SMUKERJI@MGB.ORG

Principal Investigator

Shibani S. Mukerji, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Shibani S. Mukerji, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-03
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2023-03-03
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

  • HIV
  • Depression
  • Neuroactive Steroid
  • Pregnenolone

Additional Relevant MeSH Terms

  • Major Depressive Disorder
  • Anxiety Depression
  • HIV