Last updated 2 months ago
Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
186 patients around the world
Available in Peru, Brazil, Mexico
National Institute of Allergy and Infectious Diseases (NIAID)
2Research sites
186Patients around the world
This study is for people with
Depression
Major depression
Hiv
Requirements for the patient
To 70 Years
All Gender
Medical requirements
- 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.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.
- 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.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.
Sites
Instituto Nacional de Infectologia Evandro Chagas
Asociación Civil Impacta Salud y Educación - Barranco Clinical Research Site
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Conditions
Major depressionHiv
Requirements
To 70 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06705478
