RecruitingMajor Depressive DisorderMild Neurocognitive DisorderHIV

Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

Eligible age

18–70 yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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 percent of waking hours and for over 50 percent of days over the 24 months prior to study entry.
✕ Severe, active alcohol or substance use disorder by DSM-5-TR criteria in the 6 months prior to study entry.
✕ Active alcohol or substance use judged by the investigator to interfere with the trial.
✕ Any acute infection within 14 days prior to study entry.
✕ Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to study entry.
✕ Active coronary artery disease (CAD) or myocardial infarction (MI) within 180 days prior to study entry.
✕ Presence of rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus (SLE), dermatomyositis, ulcerative colitis, Crohn's disease, or other chronic inflammatory conditions.