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.
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.
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.
Parallel
Pramipexole ER
DrugTablets self-administered orally
Escitalopram
DrugTablets self-administered orally
Change in Beck Depression Inventory-II (BDI-II/BDI-2) total score defined as the sum of all symptom scores
Occurrence of Grade ≥3 Adverse Events (AEs) or Grade ≥2 neuropsychiatric AEs related to study treatment
Occurrence of Grade ≥2 neuropsychiatric AEs related to study treatment
Change in major depressive disorder (MDD) caseness, defined as the number of symptoms present from 0 to 9, of the symptoms of major depressive disorder
Complete remission of the major depressive episode defined as a score of 0 on all of the 9 symptoms
Change in neuropsychological (NP) z-score as assessed through 4 composite domain scores
Each domain score is calculated as the average of the z-scores from the tests within the domain: * Outcome Domain 1: Cognitive Efficiency (Color Trails 1 and 2) * Outcome Domain 2: Verbal Learning and Memory (HVLT-R Learning Trials 1-3 Total and HVLT-R Delayed Recall) * Outcome Domain 3: Motor Skills (Grooved Pegboard, Non-dominant hand) * Outcome Domain 4: Language (Category Fluency Test \[Animals\])
Change in the medical outcomes study (MOS)-HIV mental health functioning summary score defined by the MOS-HIV Users Manual
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National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Cipla Ltd.
Collaborator
