RE104 Safety and Efficacy Study in Generalized Anxiety Disorder

Официальное название

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder

Обзор

The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.

Вмешательства

• Препарат RE104 for Injection
  Single, subcutaneous dose of RE104 for Injection
• Препарат Placebo
  Single, subcutaneous dose of 0.9% sodium chloride for injection

Первичные конечные точки

• RE104 30 mg versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score [Срок оценки: Week 4]

Вторичные конечные точки (5)

• RE104 30 mg versus placebo changes in total score from baseline in Hamilton Anxiety Rating Scale (HAM-A) [Срок оценки: Weeks 1, 2, 8 and 12]
• RE104 30 mg versus placebo percentage of participants with HAM-A response (≥50% reduction in score from Baseline) [Срок оценки: Weeks 1, 2, 4, 8 and 12]
• RE104 30 mg versus placebo percentage of participants with HAM-A remission (total score ≤7) [Срок оценки: Day 1 and Weeks 1, 2, 4, 8 and 12]
• RE104 30 mg versus placebo change from Baseline at Weeks 1, 2, 4, 8, and 12 in Hospital Anxiety and Depression Scale (HADS) depression subscore [Срок оценки: Weeks 1, 2, 4, 8 and 12]
• RE104 30 mg versus placebo 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 12 weeks)]

Критерии участия

Критерии включения

• Has Generalized Anxiety Disorder as defined by DSM-5-TR
• 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 an 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 other concurrent psychiatric disorders that is the primary disorder.
• 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 · 22 центра

• Lighthouse Psychiatry — Gilbert
• Preferred Research Partners, Inc. — Little Rock
• Collaborative Neuroscience Research, LLC — Garden Grove
• Kadima Neuropsychiatry Institute — La Jolla
• Open Mind Therapeutics — San Francisco
• TRIP Clinic at Psychedelic Science Institute — Santa Monica
• Innovative Clinical Research, Inc. — Lauderhill
• University of South Florida — Tampa
• … и ещё 14 центров

Идентификаторы

NCT: NCT07489651 · RE104-203-GAD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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