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

Paused · Phase 2

Conditions studied: Major Depressive Disorder, Mild Neurocognitive Disorder, HIV

In brief

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.

Key facts

Study ID

NCT06705478

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

186

Starts

2026-05-17

Expected to finish

2026-12-02

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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.
• Immune reconstitution inflammatory syndrome (IRIS) or a history of IRIS within 180 days prior to study entry.
• Unstable or advanced liver disease.
• Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry.
• Non-HIV-associated neurological disorder comorbidity.
• Diagnosis of epilepsy with antiepileptic drug treatment.
• Untreated HCV infection and HCV viremia.
• Current CNS malignant tumor or CNS opportunistic infection (OI).
• Current systemic malignant tumor or of a current systemic AIDS-defining OI.
• History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry.
• History of completed treatment of CNS OI within the 5 years prior to study entry.
• Documented history of completed treatment of systemic AIDS-defining OI, as well as Mycobacterium Tuberculosis Infection, within the 180 days prior to study entry.
• New diagnosis of syphilis or treatment for syphilis within the 180 days prior to study entry.
• History of neurosyphilis.
• Severe chronic obstructive pulmonary disease.
• Congestive heart failure (CHF).
• Use of systemic steroids daily (except testosterone).
• Diseases that cause a known bleeding diathesis.

Where it is running

• Alabama CRS — Birmingham, Alabama, United States
• University of California, Los Angeles CARE Center CRS — Los Angeles, California, United States
• UCSD Antiviral Research Center CRS — San Diego, California, United States
• University of California, San Francisco HIV/AIDS CRS — San Francisco, California, United States
• Harbor University of California, Los Angeles Center CRS — Torrance, California, United States
• University of Colorado Hospital CRS — Aurora, Colorado, United States
• Whitman-Walker Institute, Inc. CRS — Washington D.C., District of Columbia, United States
• The Ponce de Leon Center CRS — Atlanta, Georgia, United States
• Northwestern University CRS — Chicago, Illinois, United States
• Massachusetts General Hospital CRS (MGH CRS) — Boston, Massachusetts, United States
• Washington University Therapeutics (WT) CRS — St Louis, Missouri, United States
• New Jersey Medical School Clinical Research Center CRS (Site ID 31786) — Newark, New Jersey, United States
• Weill Cornell Chelsea CRS — New York, New York, United States
• Columbia Physicians & Surgeons (P&S) CRS — New York, New York, United States
• Weill Cornell Uptown CRS — New York, New York, United States
• University of Rochester Adult HIV Therapeutic Strategies Network CRS — Rochester, New York, United States
• Chapel Hill CRS — Chapel Hill, North Carolina, United States
• Greensboro CRS — Greensboro, North Carolina, United States
• Cincinnati CRS — Cincinnati, Ohio, United States
• Case CRS — Cleveland, Ohio, United States
• Ohio State University CRS — Columbus, Ohio, United States
• Penn Therapeutics CRS — Philadelphia, Pennsylvania, United States
• University of Pittsburgh CRS — Pittsburgh, Pennsylvania, United States
• Vanderbilt Therapeutics (VT) CRS — Nashville, Tennessee, United States
• Houston Advancing Research Team CRS — Houston, Texas, United States

Full record on ClinicalTrials.gov

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