RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses

Официальное название

A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses

Обзор

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.

Вмешательства

• Препарат RE104 for Injection
  Single, subcutaneous dose of RE104 for Injection

Первичные конечные точки

• RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score [Срок оценки: Day 7]

Вторичные конечные точки (2)

• RE104 30 mg versus RE104 1.5 mg changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) [Срок оценки: Day 7]
• RE104 30 mg versus RE104 1.5 mg incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness. [Срок оценки: From dosing through study completion (post-dose follow-up is for 42 days)]

Критерии участия

Критерии включения

• Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF
• Is sufficiently ambulatory and capable of self care as necessary to complete study procedures
• Has normal cognitive function
• Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study
• If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant
• Is willing and able to comply with the conditions and requirements of the study

Критерии исключения

• Has a significant risk of suicide
• Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder
• Has active or a history of central nervous system malignancy
• Has other medically significant conditions rendering unsuitability for the study
• Has used or will need to use prohibited medications or therapies
• Has a known sensitivity or intolerance to study intervention or potential rescue medications

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 · 30 центров

• UAB, Psychiatry and Behavioral Neurology — Birmingham
• University of Arizona — Tucson
• Kadima Neuropsychiatry Institute — San Diego
• Providence Medical Foundation — Santa Rosa
• University of Colorado — Aurora
• University of South Florida, Department of Psychiatry and Behavioral Neuroscience — Tampa
• Emory University — Atlanta
• Hawaii Pacific Neuroscience — Honolulu
• … и ещё 22 центра

Идентификаторы

NCT: NCT07002034 · RE104-202-ADCO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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