Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mi… (NCT06705478) | Clinical Trial Compass
RecruitingPhase 2
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
United States, Botswana, Brazil186 participantsStarted 2026-05-17
Plain-language summary
A phase II, randomized, open-label, two-arm clinical trial evaluating the safety and efficacy of pramipexole extended release (ER) versus escitalopram for the treatment of major depressive disorder (MDD) and comorbid MDD with mild neurocognitive disorder (MND) in persons with HIV (PWH). Participants will be assessed comprehensively and briefly at intercurrent visits to monitor for toxicity, response to therapy, and to assess for dose changes.
An optional sub-study to evaluate treatment impact on the cerebrospinal fluid (CSF) profile will be conducted in a subset of 36 participants.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Documented HIV-1 infection.
* Diagnosis of MDD.
* 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.
* Plasma HIV-1 RNA levels of less than 200 copies/mL obtained within 90 days prior to enrollment.
* Study candidates previously treated for depression are eligible provided the study candidate's last dose of antidepressant taken is at least 4 weeks prior to study entry, with the exception of fluoxetine, which the last dose taken must have been at least 8 weeks prior to study entry.
* Laboratory values obtained within 30 days prior to study entry that meet protocol criteria as determined by the site investigator of record.
* Study candidates of child-bearing potential must have a negative serum or urine pregnancy test performed at screening and within 2 days prior to study entry.
* Study candidates of child-bearing potential who are participating in sexual activity that could lead to pregnancy must agree to use at least one highly effective method for contraception.
Exclusion Criteria:
* Active suicidality, and/or severe MDD, psychotic disorders, manic or hypomanic symptoms occurring in the context of bipolar disorder type I or II, or cyclothymic disorder, or another current Axis I diagnosis judged by the investigator to interfere with the trial.
* Study candidate self-report of depressive symptoms that have persisted for over 50 per…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing pramipexole — a drug usually used for Parkinson's disease — against escitalopram, a standard antidepressant, for HIV-positive people with depression; given that pramipexole hasn't been widely studied for depression in people with HIV, what does my doctor think is currently known about its safety and effectiveness for someone in my situation?
2Since this is a Phase 2 trial and one of the main things being measured is how often serious side effects occur — including neuropsychiatric side effects rated Grade 2 or higher — what kinds of neuropsychiatric symptoms should I watch for, and how quickly would I be taken off the study drug if they happened?
3Because this trial also specifically enrolls people with mild neurocognitive disorder alongside depression, would my doctor need to assess whether I have any cognitive changes before I could even be considered, and how would that evaluation work?
4Escitalopram is already an approved, widely used antidepressant — could my doctor walk me through why joining a trial comparing it to pramipexole might or might not make more sense for me than simply starting standard antidepressant treatment right now?
5Given that I'm living with HIV and likely already on antiretroviral medications, would my doctor need to check whether either of these study drugs could interact with my current HIV treatment before I could safely participate?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Beck Depression Inventory-II (BDI-II/BDI-2) total score defined as the sum of all symptom scores
Timeframe: Baseline, Week 24
2
Occurrence of Grade ≥3 Adverse Events (AEs) or Grade ≥2 neuropsychiatric AEs related to study treatment
Timeframe: From study treatment administration through Week 24
3
Occurrence of Grade ≥2 neuropsychiatric AEs related to study treatment
Timeframe: From study treatment administration through Week 24
Trial details
NCT IDNCT06705478
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)