Major Depressive DisorderPhase 2NCT06705478
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
A Phase 2 study testing Pramipexole ER and Escitalopram in people with Major Depressive Disorder and Mild Neurocognitive Disorder, run by National Institute of Allergy and Infectious Diseases (NIAID) at 41 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Mild Neurocognitive Disorder, HIV
- What is being tested?
- Pramipexole ER and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 41 sitesin 14 countries
- Study dates
- 17 May 2026to 2 Dec 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 40Show fewer
- 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.
- Receipt of medications judged by the site investigator to significantly influence depression or neurocognitive function within 30 days prior to study entry.
- Non-HIV-associated neurological disorder comorbidity.
- Diagnosis of epilepsy with antiepileptic drug treatment.
- Untreated HCV infection and HCV viremia.
- Current CNS malignant tumor or CNS opportunistic infection (OI).
- Current systemic malignant tumor or of a current systemic AIDS-defining OI.
- History of completed treatment of CNS or systemic malignant tumor within the 5 years prior to study entry.
- History of completed treatment of CNS OI within the 5 years prior to study entry.
- Documented history of completed treatment of systemic AIDS-defining OI, as well as Mycobacterium Tuberculosis Infection, within the 180 days prior to study entry.
- New diagnosis of syphilis or treatment for syphilis within the 180 days prior to study entry.
- History of neurosyphilis.
- Severe chronic obstructive pulmonary disease.
- Congestive heart failure (CHF).
- Use of systemic steroids daily (except testosterone).
- Diseases that cause a known bleeding diathesis.
- Immunostimulant therapies and trials of non-FDA-approved ARV medications within 30 days prior to study entry.
- Immunosuppressive medications if judged by the investigator to affect study outcomes.
- Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding.
- Known allergy/sensitivity or any hypersensitivity to the study drugs or their formulations.
- Study candidates on prohibited medications at the time of screening will be excluded from study participation.
- Inclusion Criteria for Participants at US Sites Who Consent to the Lumbar Puncture (LP) Procedure:
- Non-focal neurological examination. Study candidates with focal findings should have expert assessment for mass effect prior to the LP.
- Laboratory values that meet LP protocol criteria as determined by the site investigator.
- Exclusion Criteria for Participants at US Sites who Consent to the LP Procedure:
- Current use of anti-coagulants.
- Known presence of intracerebral mass or lesion that is judged to affect the safety of an LP.
- Known presence of an active CNS infection that could alter CNS/CSF inflammatory measures.
- Known allergy to lidocaine.
- Individuals who are unable to safely tolerate an LP due to physical limitation or condition.
- Body mass index (BMI) greater than 40 kg/m^2.
Trial locations and contacts
41 sites in 14 countries.
41 sites in 14 countries
United States25 sites
The Ponce de Leon Center CRS
Atlanta, Georgia, 30308-2012
University of Colorado Hospital CRS
Aurora, Colorado, 80045
Alabama CRS
Birmingham, Alabama, 35222
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, 02114
Chapel Hill CRS
Chapel Hill, North Carolina, 27599-7215
Northwestern University CRS
Chicago, Illinois, 60611
Cincinnati CRS
Cincinnati, Ohio, 45267-0405
Case CRS
Cleveland, Ohio, 44106
Ohio State University CRS
Columbus, Ohio, 43210
Greensboro CRS
Greensboro, North Carolina, 27401-1020
Houston Advancing Research Team CRS
Houston, Texas, 77030
University of California, Los Angeles CARE Center CRS
Los Angeles, California, 90035
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, 37204
Weill Cornell Chelsea CRS
New York, New York, 10010
Columbia Physicians & Surgeons (P&S) CRS
New York, New York, 10032
Weill Cornell Uptown CRS
New York, New York, 10065
New Jersey Medical School Clinical Research Center CRS (Site ID 31786)
Newark, New Jersey, 07103
Penn Therapeutics CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, 14642
UCSD Antiviral Research Center CRS
San Diego, California, 92103
University of California, San Francisco HIV/AIDS CRS
San Francisco, California, 94110
Washington University Therapeutics (WT) CRS
St Louis, Missouri, 63110-1010
Harbor University of California, Los Angeles Center CRS
Torrance, California, 90502
Whitman-Walker Institute, Inc. CRS
Washington D.C., District of Columbia, 20009
Brazil2 sites
Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS
Porto Alegre, Rio Grande do Sul, 91350-180
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio de Janeiro, 21040-900
Kenya2 sites
Moi University Clinical Research Center (MUCRC) CRS
Eldoret, Rift Valley, 30100
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
Kericho, Rift Valley, 20200
Thailand2 sites
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, 50200
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathum Wan, Bangkok, 10330
India1 site
Byramjee Jeejeebhoy Medical College (BJMC) CRS
Pune, Maharashtra, 411001
Philippines1 site
De La Salle Medical and Health Sciences Institute - Angelo King Medical Research Center (DLSMHSI-AKMRC)
Dasmariñas, Cavite, 4114
About this study
Official title: 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
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
- Being tested
- Pramipexole ER, Escitalopram
- Keywords
- Comorbid MND
- Medical subject headings
- Depressive Disorder, Major, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole ERDrug
Tablets self-administered orally
EscitalopramDrug
Tablets self-administered orally
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Pramipexole ER | Experimental | Not described Receives: Drug: Pramipexole ER |
| Arm 2: Escitalopram | Experimental | Not described Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Depression Inventory-II (BDI-II/BDI-2) total score defined as the sum of all symptom scores
Measured: Baseline, Week 24
Occurrence of Grade ≥3 Adverse Events (AEs) or Grade ≥2 neuropsychiatric AEs related to study treatment
Measured: From study treatment administration through Week 24
Occurrence of Grade ≥2 neuropsychiatric AEs related to study treatment
Measured: From study treatment administration through Week 24
Secondary outcomes (8)
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
Measured: Baseline, Week 24
Complete remission of the major depressive episode defined as a score of 0 on all of the 9 symptoms
Measured: Baseline, Week 24
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])
Measured: Baseline, Week 24
Change in the medical outcomes study (MOS)-HIV mental health functioning summary score defined by the MOS-HIV Users Manual
Measured: Baseline, Week 24
Change in the MOS-HIV cognitive functioning subscale score defined by the MOS-HIV Users Manual
Measured: Baseline, Week 24
Occurrence of Grade ≥3 AEs or Grade ≥2 neuropsychiatric AEs (regardless of judged relationship to study treatment)
Measured: From study treatment administration through Week 24
Occurrence of Grade ≥2 neuropsychiatric AEs (regardless of judged relationship to study treatment)
Measured: From study treatment administration through Week 24
Number of participants with plasma HIV-1 RNA less than 50 copies/mL
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start17 May 2026
- Primary completion2 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Why it stopped: Temporarily Closed (Paused) to Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Cipla Ltd.
- Responsible party
- Sponsor
- Investigators
- William R Short, MD, Study chair, University of PennsylvaniaScott Letendre, MD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705478
- Sponsor's protocol ID
- A5402
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in publication, after deidentification.
Publications
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.
PubMed 37206666Cysique 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.
PubMed 38228906Goodkin 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.
PubMed 29668329
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06705478
- Acronym / sponsor ID
- A5402
- Conditions
- Major Depressive Disorder, Mild Neurocognitive Disorder, HIV
- Keywords
- Comorbid MND
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Temporarily Closed (Paused) to Accrual
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Cipla Ltd.
- Study start
- 17 May 2026 (actual)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Pramipexole ER | Experimental | Drug: Pramipexole ER |
| Arm 2: Escitalopram | Experimental | Drug: Escitalopram |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (40 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole ERTablets self-administered orally | Drug | Arm 1: Pramipexole ER |
| EscitalopramTablets self-administered orally | Drug | Arm 2: Escitalopram |
Primary outcome
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
Occurrence of Grade ≥3 Adverse Events (AEs) or Grade ≥2 neuropsychiatric AEs related to study treatment
Time frame: From study treatment administration through Week 24
Occurrence of Grade ≥2 neuropsychiatric AEs related to study treatment
Time frame: From study treatment administration through Week 24
8 secondary outcomes
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
Time frame: Baseline, Week 24
Complete remission of the major depressive episode defined as a score of 0 on all of the 9 symptoms
Time frame: Baseline, Week 24
Change in neuropsychological (NP) z-score as assessed through 4 composite domain scores
Time frame: Baseline, Week 24
Change in the medical outcomes study (MOS)-HIV mental health functioning summary score defined by the MOS-HIV Users Manual
Time frame: Baseline, Week 24
Change in the MOS-HIV cognitive functioning subscale score defined by the MOS-HIV Users Manual
Time frame: Baseline, Week 24
Occurrence of Grade ≥3 AEs or Grade ≥2 neuropsychiatric AEs (regardless of judged relationship to study treatment)
Time frame: From study treatment administration through Week 24
Occurrence of Grade ≥2 neuropsychiatric AEs (regardless of judged relationship to study treatment)
Time frame: From study treatment administration through Week 24
Number of participants with plasma HIV-1 RNA less than 50 copies/mL
Time frame: Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 37206666Goodkin 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: PubMed 38228906Cysique 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: PubMed 29668329Goodkin 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William R Short, MD study chair
University of Pennsylvania
Scott Letendre, MD study chair
University of California, San Diego
41 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pramipexole ER and Escitalopram in people with Major Depressive Disorder and Mild Neurocognitive Disorder, run by National Institute of Allergy and Infectious Diseases (NIAID) at 41 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Brazil, Kenya, Thailand, Botswana and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705478, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.