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

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.

Timeline

Start

2026-05-17

Primary completion

2026-12-02

Completion

2026-12-02

Publications

• Background Goodkin K, Evering TH, Anderson AM, Ragin A, Monaco CL, Gavegnano C, Avery RJ, Rourke SB, Cysique LA, Brew BJ. The comorbidity of depression and neurocognitive disorder in persons with HIV infection: call for investigation and treatment. Front Cell Neurosci. 2023 Apr 28;17:1130938. doi: 10.3389/fncel.2023.1130938. eCollection 2023.
• Background Cysique LA, Brew BJ, Bruning J, Byrd D, Costello J, Daken K, Ellis RJ, Fazeli PL, Goodkin K, Gouse H, Heaton RK, Letendre S, Levin J, Aung HL, Mindt MR, Moore D, Mullens AB, de Almeida SM, Munoz-Moreno JA, Power C, Robbins RN, Rule J, Rajasuriar R, Savin MJ, Taylor J, Trunfio M, Vance DE, Wong PL, Woods SP, Wright EJ, Rourke SB. Cognitive criteria in HIV: greater consensus is needed. Nat Rev Neurol. 2024 Feb;20(2):127-128. doi: 10.1038/s41582-024-00927-1. No abstract available.
• Background Goodkin K, Patten SB. Depressive Symptomatology, Syndromal Depression, and HIV-Associated Neurocognitive Disorder (HAND). Can J Psychiatry. 2018 May;63(5):284-286. doi: 10.1177/0706743718754537. No abstract available.

Drugs

Indications