Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)

Официальное название

A Pilot, Phase II, Open-Label, Single-Center Study of Sodium-Glucose Cotransporter-2 Inhibitor Empagliflozin in Major Depressive Disorder

Обзор

The primary purpose of this study is to determine whether empagliflozin, a medication in a class known as sodium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, may reduce symptoms of depression. Since this medication helps the body make metabolites known as ketone bodies which can serve as an alternate energy source for the brain, the investigators can also test whether ketone bodies help with depressed mood.

Вмешательства

• Препарат Empagliflozin
  The full duration of therapy will be six-weeks. The route of administration will be oral. The starting dose of the medication will be 10mg daily for the first 14 days of the study, with a dose escalation to 25mg for the last 28 days of the study.

Первичные конечные точки

• Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score [Срок оценки: Baseline, Week 6]

Вторичные конечные точки (2)

• Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score [Срок оценки: Baseline, Week 6]
• Change from Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Score [Срок оценки: Baseline, Week 6]

Критерии участия

Критерии включения

• Provide written informed consent, as approved by the NYU Institutional Research Ethic Board (IRB).
• Patients ages 18-65;
• Current/acute Major Depressive Disorder (MDD) diagnosis, per MINI psychiatric interview;
• At least moderate severity of depression (Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 20 at initial screen);

Критерии исключения

• DSM-5 diagnosis of Bipolar disorders, Cyclothymia, Schizoaffective disorder, Schizophrenia; any psychotic disorder or affective psychosis;
• Subjects that have had more than two failures of adequate anti-depressant trials in the current MDD episode;
• Subjects on psychotropic medications other than SSRIs, NDRIs, SNRIs, or mirtazapine (occasional use of sleep agents, equivalent to lorazepam 1 mg or zolpidem 10 mg, will be allowed);
• Those that have previously been on SGLT2 inhibitors;
• A significant history of non-adherence to treatments;
• History of neurologic / seizure disorder;
• A significant history of non-adherence to treatments;
• History of dementia/cognitive dysfunction (MOCA < 22);
• A primary diagnosis of a personality disorder, in the opinion of the screening clinician;
• DSM-5 substance use disorder (drug/alcohol) active within the past 12 months, or positive urine toxicology at screening;
• History of diabetic ketoacidosis;
• History of recurrent genital mycotic infection;
• GFR <45;
• HgA1c.>8.0%
• History of an allergic reaction to an SGLT2 inhibitor.
• Pregnancy or lactation (women of reproductive age, ie <50 years old, should be on licensed hormonal or barrier method contraception).
• Any known pancreatic disease resulting in insulin deficiency (T1D, history of pancreatitis, pancreatic surgery);
• History of liver or kidney disease;
• Hypersensitivity to empagliflozin or any of the excipients in JARDIANCE.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT05757791 · 23-00027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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