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

NOT_YET_RECRUITINGPHASE2

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

An Open-Label, Randomized Controlled Trial of Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV

NCT06705478•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
•Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP.
+2 more criteria

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 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.
+26 more criteria

Locations (40)

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

Key Dates

Start Date

February 15, 2026

Primary Completion Date

December 2, 2026

Completion Date

December 2, 2026

Last Updated

January 15, 2026

Enrollment

186

ESTIMATED participants

Conditions

Major Depressive DisorderMild Neurocognitive DisorderHIV

Interventions

Pramipexole ER

DRUG

Escitalopram

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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