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Идёт набор NCT07276997

A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With 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: Icalcaprant, Placebo for Icalcaprant.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder. Базовые параметры: 18 лет — 65 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
США
Следующий шаг
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Официальное название

A Phase 2, Multicenter, 6-Week, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Icalcaprant in Subjects With Major Depressive Disorder

Обзор

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

  • Препарат Icalcaprant
    Oral Capsules
  • Препарат Placebo for Icalcaprant
    Oral Capsules

Первичные конечные точки

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score. [Срок оценки: Up to approximately 6 weeks]
  • Number of Participants with Adverse Events (AEs) [Срок оценки: Up to approximately 10 weeks]
Вторичные конечные точки (1)
  • Change from Baseline in Clinical Global Impression (CGIS) [Срок оценки: Up to approximately 6 weeks]

Критерии участия

Критерии включения

  • Participants with a diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, fifth edition, text revision (DSM-5-TR) without psychotic features, confirmed by the Mini International Neuropsychiatric Interview (MINI) 7.0.
  • Body Mass Index (BMI) is ≥ 18.0 to ≤ 35.0 kg/m\^2
  • Currently experiencing an major depressive episode (MDE) beginning at least 4 weeks prior to consent and not exceeding 6 months prior to Screening
  • Normal physical examination findings, clinical laboratory test results, vital signs, and 12-lead ECG results at Visit 1 or abnormal results that are judged not clinically significant by the investigator and documented as such in the eCRF.

Критерии исключения

  • Has failed (no more than 25% response on Antidepressant Treatment History Questionnaire (ATRQ)) 3 or more antidepressant treatments during the current depressive episode despite an adequate dose (per ATRQ) and duration (at least 6 weeks).
  • History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.

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

США · 33 центра
  • Harmonex /ID# 277517 — Dothan
  • Ima Clinical Research Phoenix (Alea) /ID# 277516 — Phoenix
  • Preferred Research Partners /ID# 279206 — Little Rock
  • Woodland International Research Group /ID# 277605 — Little Rock
  • Advanced Research Center /ID# 277537 — Anaheim
  • Sun Valley Research Center /ID# 277513 — Imperial
  • Synergy San Diego /ID# 277553 — Lemon Grove
  • Accellacare - Long Beach /ID# 279181 — Long Beach
  • … и ещё 25 центров

Идентификаторы

NCT: NCT07276997 · M25-987

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗