Neuroinflammation and Modulating Factors in Depression and HIV

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: HIV; Depression

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04286282

STUDY00006374

K23MH121220 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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109 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

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

Treatment:

Other: Depression Standard of Care

Other: HIV Standard of Care

Standard of Care + Group Support Psychotherapy

Experimental group

Description:

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

Treatment:

Other: Depression Standard of Care

Behavioral: Group Pyschotherapy

Other: HIV Standard of Care

Standard of Care (Non-Depressed)

Active Comparator group

Description:

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

Treatment:

Other: HIV Standard of Care