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

Conditions

• HIV
• Major Depressive Disorder
• Mild Neurocognitive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Pramipexole ER — DRUG
  Tablets self-administered orally
• Escitalopram — DRUG
  Tablets self-administered orally

Study Details

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 Dates

Start date

May 17, 2026

Status verified

May 2026

Primary completion

Dec 2, 2026

Completion

Dec 2, 2026

Study Design

Enrollment

186 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Pramipexole ER
• Experimental: Arm 2: Escitalopram

Primary Outcome Measure

Change in Beck Depression Inventory-II (BDI-II/BDI-2) total score defined as the sum of all symptom scores [ Time Frame: Baseline, Week 24 ]

Locations (25)

Find similar trials in Birmingham, AL

Related Studies

• Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV
  Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Washington D.C., District of Columbia
• The Use of Leukapheresis to Support HIV Pathogenesis Studies
  Recruiting · University of California, San Francisco · San Francisco, California
• The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
  Recruiting · University of California, San Francisco · San Francisco, California
• The DC Cohort Longitudinal HIV Status Neutral Study
  Recruiting · George Washington University · Washington D.C., District of Columbia