Neuroinflammation and Modulating Factors in Depression and HIV

NCT04286282 | Completed Phase 2 Results DMC

• 2 other identifiers: STUDY00006374K23MH121220
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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 which group psychotherapy is initiated.

Conditions

Depression; HIV

Outcome Measures

Primary Outcomes (2)

• Change in Patient Health Questionnaire (PHQ)-9

  The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 3 months

  3 months

• Change in Patient Health Questionnaire (PHQ)-9

  The Patient Health Questionnaire (PHQ)-9 is a 9-item survey measuring degree of depression severity over the previous 2 weeks. Items assess how often the patient has been bothered by specific symptoms and are rated on a scale of 0 (not at all) to 3 (nearly every day). Total score is an unweighted sum of the 9 item scores, with higher scores indicating greater depression severity. a score of 0-27 is possible. We aren't reporting subscales. A score of 5+ will screen positive for mild depression, and a score of 10+ is considered a positive to screen for moderate-severe depression. change between baseline and 6 months

  6 months

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.

Other: Depression Standard of Care; Other: HIV Standard of Care

Standard of Care + Group Support Psychotherapy

EXPERIMENTAL

The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.

Behavioral: Group Pyschotherapy; Other: Depression Standard of Care; Other: HIV Standard of Care

Standard of Care (Non-Depressed)

ACTIVE COMPARATOR

100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment.

Other: HIV Standard of Care

Interventions

Group Pyschotherapy BEHAVIORAL

Group psychotherapy

Standard of Care + Group Support Psychotherapy

Depression Standard of Care OTHER

Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).

Standard of Care; Standard of Care + Group Support Psychotherapy

HIV Standard of Care OTHER

Standard clinical care for HIV

Standard of Care; Standard of Care (Non-Depressed); Standard of Care + Group Support Psychotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Infectious Diseases Institute

Kampala, Uganda

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Sarah Lofgren
• Organization: University of Minnesota

Lofg0020@umn.edu

612-624-9996

Study Officials

• Sarah Lofgren, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: February 1, 2021
• Primary Completion: November 9, 2023
• Study Completion: April 9, 2024
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Locations

UG (1)