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Pramipexole vs Escitalopram for Depression in HIV
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
On current ART regimen for at least 90 days prior to study entry with no interruption in treatment greater than 7 consecutive days
No plans to change ART while on study
Must not have
Untreated HCV infection and HCV viremia
Current CNS malignant tumor or CNS opportunistic infection (OI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24
Awards & highlights
No Placebo-Only Group
Summary
This trial is comparing the safety and effectiveness of two different medications, pramipexole extended release and escitalopram, for treating major depressive disorder (MDD) in people with HIV.
Who is the study for?
This trial is for individuals with HIV who are experiencing major depressive disorder (MDD) and may also have mild neurocognitive disorder (MND). Specific eligibility criteria details were not provided, so interested participants should inquire further to determine if they qualify.
What is being tested?
The study compares the safety and effectiveness of two medications: Pramipexole ER, a drug often used for Parkinson's disease, against Escitalopram, a common antidepressant. It aims to see which is better for treating depression in people with HIV.
What are the potential side effects?
While specific side effects aren't listed here, Pramipexole can typically cause dizziness or sleepiness; Escitalopram might lead to nausea or headache. Participants will be monitored regularly for any adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on my current HIV treatment for at least 90 days without a break longer than a week.
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I do not plan to change my HIV medication during the study.
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I have been diagnosed with major depressive disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active hepatitis C infection that hasn't been treated.
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I do not have a current brain tumor or brain infection.
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I do not have an active cancer or a severe infection related to AIDS.
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I have epilepsy and am taking medication for it.
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I haven't been hospitalized or needed serious treatment in the last 3 months.
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My liver disease is severe or getting worse.
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I have been treated for a brain or other cancer more than 5 years ago.
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I have severe COPD.
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I have a condition that increases my risk of bleeding.
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I have had neurosyphilis in the past.
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I have been diagnosed with congestive heart failure.
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I take daily steroids, not including testosterone.
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I am not taking any medications that are not allowed in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in neuropsychological (NP) z-score as assessed through 4 composite domain scores
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2: EscitalopramExperimental Treatment1 Intervention
Group II: Arm 1: Pramipexole ERExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
2005
Completed Phase 4
~2330
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,382,648 Total Patients Enrolled
Cipla Ltd.Industry Sponsor
9 Previous Clinical Trials
28,621 Total Patients Enrolled
Karl Goodkin, MD, PhDStudy ChairNeuropsychiatrist Consultant