Clinical Trials

MainTitle

Neuroinflammation and Modulating Factors in Depression and HIV

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified February 2020 by University of Minnesota

Sponsor
University of Minnesota

Collaborator
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
University of Minnesota
ClinicalTrials.gov Identifier
NCT04286282

First received: February 24, 2020
Last updated: February 24, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
Depression
HIV

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda

Further study details as provided by University of Minnesota:

Primary Outcome Measures

  • Change in Patient Health Questionnaire (PHQ)-9 [ Time Frame: Baseline, 26 weeks ]
    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.
  • Change in Plasma Interleukin (IL)-6 Concentration [ Time Frame: Baseline, 26 weeks ]
    Plasma concentration of IL-6 will be measured using Luminex magnetic bead technology and reported in ng/ml.
  • Change in Morning Plasma Cortisol Concentration [ Time Frame: Baseline, 26 weeks ]
    Plasma cortisol concentration will be measured with enzyme-linked immunosorbant assay (ELISA) and reported in ng/ml.

Estimated Enrollment: 300
Anticipated Study Start Date: September 1, 2020
Estimated Study Completion Date: September 30, 2022
Estimated Primary Completion Date: September 30, 2022 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Standard of Care
The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Other: Depression Standard of Care

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

Other: HIV Standard of Care

Standard clinical care for HIV

Experimental: Standard of Care + Group Support Psychotherapy
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
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).

Other: HIV Standard of Care

Standard clinical care for HIV

Active Comparator: Standard of Care (Non-Depressed)
100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment.
Other: HIV Standard of Care

Standard clinical care for HIV

Detailed 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.
te if viral suppression levels at 26 weeks are improved by group psychotherapy.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 65 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04286282

Contacts

Contact:   Sarah Lofgren, MD 612-624-9996 lofg0020@umn.edu

Locations

Uganda
Infectious Diseases Institute
Kampala, Uganda

Sponsors and Collaborators

University of Minnesota
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Sarah Lofgren, MD University of Minnesota
More Information

More Information


Responsible Party: University of Minnesota  
ClinicalTrials.gov Identifier: NCT04286282   History of Changes  
Other Study ID Numbers: STUDY00006374  
  K23MH121220  
Study First Received: February 24, 2020  
Last Updated: February 24, 2020  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Additional relevant MeSH terms:
Depression
Depressive Disorder

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.