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Идёт набор NCT07172516

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Фаза III С лечением Bipolar Disorder Bipolar Depression Bipolar I Disorder Bipolar II 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: Azetukalner, Placebo.
Кому может быть актуально
Состояния в реестре: Bipolar Disorder, Bipolar Depression, Bipolar I Disorder, Bipolar II Disorder. Базовые параметры: 18 лет — 74 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Azetukalner in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Обзор

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

Вмешательства

  • Препарат Azetukalner
    Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
  • Препарат Placebo
    Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Первичные конечные точки

  • Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. [Срок оценки: Baseline to Week 6]
Вторичные конечные точки (3)
  • Change from baseline in the Clinical Global Impression of Severity (CGI-S) score at Week 6. [Срок оценки: Baseline to Week 6]
  • Change from baseline in the MADRS total score at Week 1. [Срок оценки: Baseline to Week 1]
  • Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score at Week 6. [Срок оценки: Baseline to Week 6]

Критерии участия

Критерии включения

  • Adults ≥18 and ≤74 years of age who experienced their first major depressive episode (MDE) prior to 50 years of age.
  • Body Mass Index (BMI) ≥18 kg/m2 and ≤40 kg/m2.
  • Meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for bipolar I or II disorder and is currently in a MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI).
  • Current MDE must has a duration of ≥4 weeks and ≤12 months.

Критерии исключения

  • Participant has any type of major depressive disorder (MDD) diagnosis, including MDD with psychotic features, MDD with catatonia, MDD with seasonal pattern, or postpartum depression.
  • Participant has any nonbipolar psychiatric diagnosis.
  • Participant has a substance use disorder (excluding tobacco) within the 6 months prior to screening visit.
  • Participant has a symptomatic eating disorder within the 12 months prior to screening visit.
  • Participant has a Young Mania Rating Scale (YMRS) score >12 points at screening visit or randomization.
  • Participant has been hospitalized for mania within the 30 days prior to screening visit.
  • Participant is considered treatment-resistant in the current bipolar depressive episode, defined as having treatment resistance (no remission) to ≥2 different medications approved by the regional regulatory authority at an adequate dose (per regulatory approved label) and for an adequate duration (at least 6 weeks).
  • Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 12 months.
  • Participant has self-injurious behavior without intent to die in the 12 months prior to screening.
  • Participant has used antidepressants, mood stabilizers, anticonvulsants, antipsychotics, or other prohibited medications within the 1 week or within a period less than 5 times the drug's half-life, whichever is longer prior to randomization.
  • Participants with medical conditions that may interfere with the purpose or conduct of the study.
  • Participant is pregnant, breastfeeding, or planning to become pregnant.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 28 центров
  • Noble Clinical Research — Tucson
  • Woodland International Research Group — Little Rock
  • Woodland Research Northwest — Rogers
  • Clinical Innovations Inc — Bellflower
  • ProScience Research Group — Culver City
  • ATP Clinical Research — Orange
  • NRC Research Institute — Orange
  • Clinical Innovations Inc — Riverside
  • … и ещё 20 центров

Идентификаторы

NCT: NCT07172516 · XPF-010-B301

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗