Skip to main content
OpenTrials
Completed

NCT Number: NCT04286282

Neuroinflammation and Modulating Factors in Depression and HIV

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Infectious Diseases Institute

Kampala, Uganda

About this study

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 cause depression. Inflammation caused by diseases such as stroke, diabetes, and HIV is associated with higher rates of depression. HIV causes inflammation throughout the body, but since the virus can cross the blood-brain-barrier, HIV can replicate in and target the brain causing neuroinflammation which predisposes depression. However the pathophysiology of the role of inflammation in comorbid depression and HIV is poorly understood.

  • Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy.
  • In the same population determine if persistent depression is associated with higher levels of innate inflammation. Also, compare baseline and follow up inflammation among depressed compared to non-depressed control group.
  • Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • No additional exclusion criteria

Treatment and study plan

Group Pyschotherapy

Behavioral

Group psychotherapy

Depression Standard of Care

Other

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

HIV Standard of Care

Other

Standard clinical care for HIV

Primary outcomes

  1. Change in Patient Health Questionnaire (PHQ)-9

    Time frame: 3 months

    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

  2. Change in Patient Health Questionnaire (PHQ)-9

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 26, 2020
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.