Phase 2 N=109 Treatment

Neuroinflammation and Modulating Factors in Depression and HIV

Depression · HIV

Bottom Line

View on ClinicalTrials.gov: NCT04286282 ↗

Enrolled (actual)

109

Serious AEs

—

Results posted

Jan 2025

Primary outcome: Primary: Change in Patient Health Questionnaire (PHQ)-9 — 5; 7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Group Pyschotherapy (Behavioral); Depression Standard of Care (Other); HIV Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Nov 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Patient Health Questionnaire (PHQ)-9	7; 8	—
PRIMARY Change in Patient Health Questionnaire (PHQ)-9	7; 8	—

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 which group psychotherapy is initiated.

Eligibility Criteria

Inclusion Criteria

For the depressed patient arm,

Newly-presenting clinic patients ( 5 but 2)
Not receiving antiretroviral therapy (ART) at screening
Outpatient, not requiring hospitalization

For the non-depressed patient arm,

Newly-presenting clinic patients ( 2)
Not receiving antiretroviral therapy (ART) at screening
Outpatient, not requiring hospitalization

Exclusion Criteria

No additional exclusion criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04286282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.