Phase 2
Completed N=109
Neuroinflammation and Modulating Factors in Depression and HIV
Source: ClinicalTrials.gov NCT04286282 ↗Enrolled (actual)
109
Serious AEs
—
Results posted
Jan 2025
Primary outcomePrimary: Change in Patient Health Questionnaire (PHQ)-9 — 5; 7 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Health Questionnaire (PHQ)-9 |
7; 8 | — |
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
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. Informational only — not medical advice.