NCT06705478

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder
• Mild Neurocognitive Disorder
• HIV

Interventions

Type	Name	Description
DRUG	Pramipexole ER	Tablets self-administered orally
DRUG	Escitalopram	Tablets self-administered orally

Timeline

• Start date: 2026-04-30
• Primary completion: 2026-12-02
• Completion: 2026-12-02
• First posted: 2024-11-26
• Last updated: 2026-03-31

Locations

40 sites across 14 countries: United States, Botswana, Brazil, India, Kenya, Malawi, Mexico, Peru, Philippines, South Africa, Thailand, Uganda, Vietnam, Zimbabwe

Regulatory

• FDA-regulated drug study