A Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of (R)-Ketamine Hydrochloride Nasal Spray in Patients With Depression and Acute Suicidal Ideation or Behavior

Официальное название

A Randomized, Double-blind, Placebo-controlled Phase Il Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of (R)-Ketamine Hydrochloride Nasal Spray in Patients With Depression and Acute Suicidal Ideation or Behavior

Обзор

The purpose of this study is to learn about: * To evaluate the efficacy of PRT-042 nasal spray for the Rapid Reduction of the depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior * To evaluate the safety and pharmacokinetic (PK) characteristics after multiple dose of PRT-042 nasal spray in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior

Вмешательства

• Препарат Low Dose PRT042 nasal spray
  two times a week, for 4 weeks
• Препарат median Dose PRT042 nasal spray
  two times a week, for 4 weeks
• Препарат high dose PRT042 nasal spray
  two times a week, for 4 weeks
• Препарат placebo
  two times a week, for 4 weeks

Первичные конечные точки

• Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at 24 Hours After the First Dose (Day 2) [Срок оценки: Baseline (Day 1, predose) and 24 hours first post dose (Day 2)]

Вторичные конечные точки (12)

• Change From Baseline in Montgomery Asberg Depression Rating Scale Total Score During Double-blind Phase [Срок оценки: Days 1 (4 hours postdose), 4, 8, 11, 15, 18, 22 and Day 25]
• Number of Participants who Achieved Response （≥50% decrease from baseline MADRS total score）Through the Double-blind Phase [Срок оценки: Days 1 (4 hours postdose),2, 4, 8, 11, 15, 18, 22 and Day 25]
• Number of Participants Who Achieved Remission (MADRS Total Score Less Than or Equal to [<=] 12) Through the Double-blind Phase [Срок оценки: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25]
• 5. Change From Baseline in Clinical Global Impression- Severity of Suicidality-Revised (CGI-SS-R) During Double-blind Phase [Срок оценки: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25]
• Number of Participants Who Achieved Resolution of Suicidality (CGI-SS-R Score of 0 or 1) Through Double-blind Phase [Срок оценки: up to Day 25]
• Change From Baseline in Clinical Global Impression of Imminent Suicide Risk (CGI-SR-I) Scale Total Score During Double-blind Phase [Срок оценки: Days 1 (4 hours postdose), 2, 4, 8, 11, 15, 18, 22 and Day 25]
• 8. Change From Baseline in Beck Hopelessness Scale (BHS) Total Score During Double-blind Phase [Срок оценки: Baseline, Days 8 ,15 and 25]
• Change From Baseline in Beck Scale for Suicide Ideation -Chinese Version (BSI-CV) Total Score During Double-blind Phase [Срок оценки: Baseline, Days 8 ,15 and 25]
• Number of Participants With Treatment Emergent Adverse Events (TEAEs)、Vital Signs Abnormalities、Abnormal Electrocardiogram (ECG) Values et al: DB Treatment Phase [Срок оценки: up to Day 25]
• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) [Срок оценки: up to Day 25]
• Maximum Plasma Concentration [Cmax] [Срок оценки: up to Day 25]
• plasma elimination half-life [T1/2] [Срок оценки: up to Day 25]

Критерии участия

Критерии включения

• Participant must meet Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment and confirmed by the Mini International Psychiatric Interview (MINI) .
• Participants must have current suicidal ideation with intent, confirmed by a "Yes" response to Question B3 \[Think (even momentarily) about harming or of hurting or of injuring yourself: with at least some intent or awareness that you might die as a result; or think about suicide (ie, about killing yourself)?\] and Question B10 \[Intend to act on thoughts of killing yourself?\] obtained from the MINI.
• Participant has a Montgomery Asberg Depression Rating Scale (MADRS) total score of greater than (≥) 28 and the score for item 10"suicide ideation" of greater than (≥) 3 predose on Day 1

Критерии исключения

• Participant has a current DSM-5 diagnosis of bipolar (or related disorders), antisocial personality disorder, or obsessive compulsive disorder.
• Participant has a current clinical diagnosis of autism, dementia, or intellectual disability.
• Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychotic features .
• Participant meets the DSM-5 severity criteria for moderate or severe substance or alcohol use disorder, within the 6 months before screening
• Participant has a current or prior diagnosis of a reatment resistant depression
• Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
• Participant has a history of malignancy within 5 years before screening
• Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
• Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.

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

Китай · 8 центров

• BEIjing AnDing hospital capital medical university — Пекин
• Beijing AnDing hospital capital medical university — Пекин
• Beijing Huilongguan Hospital — Пекин
• The Fourth People's Hospital of Chengdu — Чэнду
• Hangzhou Seventh People's Hospital — Ханчжоу
• The fourth affiliated hospital of Anhui medical university — Хэфэй
• The affiliated Kangning Hospital of Ningbo University — Ningbo
• Suzhou Guangji Hospital — Сучжоу

Идентификаторы

NCT: NCT07193901 · PRT042-II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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