Neuroinflammation and Modulating Factors in Depression and HIV

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286282
• Other study ID #: STUDY00006374
• Secondary ID: K23MH121220
• Status: Completed
• Phase: Phase 2
• Start date: February 1, 2021
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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. 1. Among depressed HIV-infected Ugandans, determine if the resolution of depression at 26 weeks of HIV therapy is improved with group psychotherapy. 2. 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. 3. Evaluate if viral suppression levels at 26 weeks are improved by group psychotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 9, 2023
• Est. primary completion date: November 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• HIV

Intervention

Behavioral:
• Group Pyschotherapy
Group psychotherapy

Other:
• Depression Standard of Care
Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
• HIV Standard of Care
Standard clinical care for HIV

Locations

Country	Name	City	State
Uganda	Infectious Diseases Institute	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 26 weeks
Primary	Change in Plasma Interleukin (IL)-6 Concentration	Plasma concentration of IL-6 will be measured using Luminex magnetic bead technology and reported in ng/ml.	Baseline, 26 weeks
Primary	Change in Morning Plasma Cortisol Concentration	Plasma cortisol concentration will be measured with enzyme-linked immunosorbant assay (ELISA) and reported in ng/ml.	Baseline, 26 weeks