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Neuroinflammation and Modulating Factors in Depression and HIV

Primary Purpose

Depression, HIV

Status
Recruiting
Phase
Phase 2
Locations
Uganda
Study Type
Interventional
Intervention
Group Pyschotherapy
Depression Standard of Care
HIV Standard of Care
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Infectious Diseases InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Standard of Care

Standard of Care + Group Support Psychotherapy

Standard of Care (Non-Depressed)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
Change in Morning Plasma Cortisol Concentration
Plasma cortisol concentration will be measured with enzyme-linked immunosorbant assay (ELISA) and reported in ng/ml.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2020
Last Updated
October 29, 2022
Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04286282
Brief Title
Neuroinflammation and Modulating Factors in Depression and HIV
Official Title
Neuroinflammation and Modulating Factors in Depression and HIV: The Growth Study-Group Therapy in HIV for Depression IN Uganda
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
The first 100 participants with HIV and depression will receive standard of care including SSRI therapy.
Arm Title
Standard of Care + Group Support Psychotherapy
Arm Type
Experimental
Arm Description
The second 100 participants with HIV and depression will receive standard of care, including SSRI therapy, and group support psychotherapy.
Arm Title
Standard of Care (Non-Depressed)
Arm Type
Active Comparator
Arm Description
100 participants with HIV and without depression will receive standard of care therapy for HIV and no depression treatment.
Intervention Type
Behavioral
Intervention Name(s)
Group Pyschotherapy
Intervention Description
Group psychotherapy
Intervention Type
Other
Intervention Name(s)
Depression Standard of Care
Intervention Description
Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
Intervention Type
Other
Intervention Name(s)
HIV Standard of Care
Intervention Description
Standard clinical care for HIV
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ)-9
Description
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.
Time Frame
Baseline, 26 weeks
Title
Change in Plasma Interleukin (IL)-6 Concentration
Description
Plasma concentration of IL-6 will be measured using Luminex magnetic bead technology and reported in ng/ml.
Time Frame
Baseline, 26 weeks
Title
Change in Morning Plasma Cortisol Concentration
Description
Plasma cortisol concentration will be measured with enzyme-linked immunosorbant assay (ELISA) and reported in ng/ml.
Time Frame
Baseline, 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Lofgren, MD
Phone
612-624-9996
Email
lofg0020@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Lofgren, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Infectious Diseases Institute
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Akinyange
First Name & Middle Initial & Last Name & Degree
Anita Arinda

12. IPD Sharing Statement

Learn more about this trial

Neuroinflammation and Modulating Factors in Depression and HIV

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