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Идёт набор NCT04637620

NMDA Modulation in Major Depressive Disorder

Фаза II С лечением Major Depressive Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: NMDAE, Sertraline, Placebo Cap.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder. Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Тайвань
Следующий шаг
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Обзор

Most of the current antidepressants for major depressive disorder (MDD) are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. NMDA hypofunction has been implicated in the pathophysiology of depression. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of an NMDA enhancer (NMDAE) in the treatment of MDD in the adults.

Подробное описание

Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the general adults by comparing with sertraline (a selective serotonin reuptake inhibitor \[SSRI\]) and placebo. The investigators will enroll non-elderly adult patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigators will biweekly measure clinical performances and side effects. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The efficacy of three groups will be compared.

Вмешательства

  • Препарат NMDAE
    Use of an NMDA enhancer for the treatment of MDD
  • Препарат Sertraline
    Use of SSRI as an active comparator
  • Препарат Placebo Cap
    Use of placebo as a comparator

Первичные конечные точки

  • Change in Hamilton Rating Scale for Depression [Срок оценки: week 0, 2, 4, 6, 8]
  • Change in Global Assessment of Functioning [Срок оценки: Week 0, 2, 4, 6, 8]
Вторичные конечные точки (12)
  • Change in Perceived Stress Scale [Срок оценки: week 0, 2, 4, 6, 8]
  • Visual Analogue Scale (VAS) [Срок оценки: week 0, 2, 4, 6, 8]
  • Clinical Global Impression [Срок оценки: week 0, 2, 4, 6, 8]
  • Quality of life (SF-36) [Срок оценки: week 0, 8]
  • Visual Continuous Performance Test [Срок оценки: week 0, 8]
  • Wisconsin Card Sorting Test [Срок оценки: week 0, 8]
  • Logical Memory Test of the Wechsler Memory Scale [Срок оценки: week 0, 8]
  • Digit Span [Срок оценки: week 0, 8]
  • Spatial Span [Срок оценки: week 0, 8]
  • Category Fluency [Срок оценки: week 0, 8]
  • Trail Marking A [Срок оценки: week 0, 8]
  • WAIS-III Digit Symbol-Coding [Срок оценки: week 0, 8]

Критерии участия

Критерии включения

  • Have a DSM-5 (American Psychiatric Association) diagnosis of MDD
  • 17-item Hamilton Rating Scale for Depression total score ≥ 18
  • Free of antidepressant drugs for at least 2 weeks
  • Agree to participate in the study and provide informed consent

Критерии исключения

  • Current substance abuse or history of substance dependence in the past 6 months
  • History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study
  • Bipolar depression, schizophrenia or other psychotic disorder
  • Moderate-severe suicidal risks
  • Severe cognitive impairment
  • Initiating or stopping formal psychotherapy within six weeks prior to enrollment
  • A history of severe adverse reaction to SSRIs
  • A treatment-resistant history (that is, they have failed to respond to two or more different classes of antidepressants with adequate dosage and treatment duration
  • A history of previously received electroconvulsive therapy
  • Inability to follow protocol

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Тайвань · 1 центр
  • Department of Psychiatry, China Medical University Hospital — Taichung

Идентификаторы

NCT: NCT04637620 · CMUH103-REC2-130

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗