Status:

COMPLETED

Neuroinflammation and Modulating Factors in Depression and HIV

Lead Sponsor:

University of Minnesota

Collaborating Sponsors:

National Institute of Mental Health (NIMH)

Conditions:

Depression

HIV

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

Determine if depression, which persists after depression treatment at 26 weeks, is associated with increased innate inflammation in a prospective cohort of HIV-infected Ugandans receiving SSRIs in whi...

Detailed Description

Depression in HIV is a complex co-morbidity with both social factors such as stigma as well as biologic components. Disruptions in neurotransmitters such as serotonin and catecholamines are known to c...

Eligibility Criteria

Inclusion

  • For the depressed patient arm,
  • Newly-presenting clinic patients (\<3 months)
  • Mild to Moderately-Severe Depressive Symptoms with PHQ-9 score \>5 but \<20
  • Not suicidal (PHQ-9 question 9 score \>2)
  • Not receiving antiretroviral therapy (ART) at screening
  • Outpatient, not requiring hospitalization
  • For the non-depressed patient arm,
  • Newly-presenting clinic patients (\<3 months)
  • Not suicidal (PHQ-9 question 9 score \>2)
  • Not receiving antiretroviral therapy (ART) at screening
  • Outpatient, not requiring hospitalization

Exclusion

  • \- No additional exclusion criteria

Key Trial Info

Start Date :

February 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 9 2024

Estimated Enrollment :

109 Patients enrolled

Trial Details

Trial ID

NCT04286282

Start Date

February 1 2021

End Date

April 9 2024

Last Update

January 9 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Infectious Diseases Institute

Kampala, Uganda