A Study of Seltorexant as Monotherapy in Adults and Elderly Participants With Major Depressive Disorder

Официальное название

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate Efficacy and Safety of Seltorexant as Monotherapy in Adult and Elderly Participants With Major Depressive Disorder (MDD) and an Open-label Long-term Extension Treatment With Seltorexant

Обзор

The main purpose of this study is to assess how well the study drug (JNJ-42847922) works (efficacy) compared with placebo in improving depressive symptoms in participants with major depressive disorder (\[MDD\], a common mood disorder that causes a lasting feeling of sadness and a loss of interest in everyday activities) in double-blind treatment phase. Further, to evaluate long-term safety and tolerability of JNJ-42847922 in participants with MDD in the open label treatment phase.

Вмешательства

• Препарат Seltorexant
  Seltorexant tablet will be administered orally.
• Препарат Placebo
  Placebo tablet will be administered orally.

Первичные конечные точки

• Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS) [Срок оценки: Baseline up to Day 43]
• Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs) [Срок оценки: OL Baseline (Day 43) Up to 6 months]
• OL Treatment Phase: Number of Participants with Vital Signs Abnormalities [Срок оценки: OL Baseline (Day 43) Up to 6 months]
• OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: OL Baseline (Day 43) Up to 6 months]
• OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20) [Срок оценки: End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days)]
• OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG) [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX) [Срок оценки: Up to 6 months]
• OL Treatment Phase: Change from Baseline in the Body Weight [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI) [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline in the Waist Circumference [Срок оценки: OL Baseline (Day 43) up to 6 months]

Вторичные конечные точки (12)

• DB Treatment Phase: Change from Baseline in MADRS-Without Sleep Item (WOSI) Total Score [Срок оценки: Baseline up to Day 43]
• DB Treatment Phase: Change from Baseline in Sleep Disturbance using Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 10a(8a + 2a ) T-score [Срок оценки: Baseline up to Day 43]
• DB Treatment phase: Change from Baseline in MADRS-6 Total Score [Срок оценки: Baseline up to Day 43]
• DB Treatment Phase: Proportion of Participants with Response on Depressive Symptoms Scale [Срок оценки: Baseline up to Day 43]
• DB Treatment Phase: Change from Baseline in Sleep Disturbance using PROMIS-SD Short Form 8a T-Score [Срок оценки: Baseline up to Day 43]
• DB Treatment Phase: Change from Baseline in Patient Health Questionnaire 9-Item (PHQ-9) Total Score [Срок оценки: Baseline up to Day 43]
• DB Period: Change from Baseline in Work Productivity and Activity Impairment Questionnaire, Depression (WPAI-D) Scores [Срок оценки: Baseline up to Day 43]
• OL Treatment Phase: Change from Baseline Over Time in MADRS Total Score [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline Over Time in Clinical Global Impression-Severity (CGI-S) Score [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline Over Time in MADRS-WOSI Total Score [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline Over Time in Sleep Disturbance using PROMIS-SD Short Form 10a(8a+2a) T-score [Срок оценки: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline in Work Productivity and Activity Impairment-Questionnaire Depression (WPAI-D) Score [Срок оценки: OL Baseline (Day 43) up to 6 months]

Критерии участия

Критерии включения

• 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
• Experienced at least one MDD episode prior to their current episode
• Current episode of MDD must be a minimum of 2 weeks in duration
• Must meet one of the following criteria regarding current medication status.

• Can be presenting for a new episode of MDD on no antidepressant treatment; however, must have been treated with an antidepressant medication in a prior episode for a minimum of 6 weeks at a stable dose at or above the minimum therapeutic level (medical record/source document).

OR

• Have taken up to two antidepressant treatments started in the current episode that were stopped (withdrawn), or will be withdrawn (washed out) due to inadequate response or intolerance.
• Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\^2)
• Must be medically stable on the basis of the following performed at screening and double-blind (DB) baseline: physical examination (including a brief neurological examination), vital signs (including blood pressure), and 12-lead electrocardiogram (ECG)

Критерии исключения

• Use of ketamine/esketamine in the current depressive episode (up to 2 doses are allowed prior to screening)
• Has treatment-resistant depression (TRD)
• Has a primary DSM-5 diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia which has been the primary focus of psychiatric treatment within the past 2 years
• Current active DSM-5 diagnosis of obsessive-compulsive disorder, posttraumatic stress disorder, anorexia nervosa, bulimia nervosa, or fibromyalgia
• Has a history or current diagnosis of a psychotic disorder, bipolar disorder, autism spectrum disorder, borderline personality disorder, or somatoform disorders
• Has dementia, any dementing disease, intellectual disability, or neurocognitive disorder
• Has a current or recent history of homicidal ideation or serious suicidal ideation within the past 3 months or a history of suicidal behavior within the past 6 months
• Has a history of moderate-to-severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months
• Has any significant sleep disorder, including but not limited to untreated/uncontrolled conditions
• Has known allergies, hypersensitivity, intolerance, or any contraindication to seltorexant or its excipients

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

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 26 центров

• CI Trials — Bellflower
• Behavioral Research Specialists LLC — Glendale
• Excell Research Inc — Oceanside
• NRC Research Institute — Orange
• Cenexel — Riverside
• Sunwise Clinical Research — Walnut Creek
• UHC Research — Doral
• Reliable Clinical Research — Hialeah
• … и ещё 18 центров

Тайвань · 2 центра

• Taipei Medical University Hospital — Taipei
• Taipei Veterans General Hospital — Taipei

Бразилия · 1 центр

• Centro Integrado Facili — São Bernardo do Campo

Малайзия · 1 центр

• University Malaya Medical Centre — Kuala Lumpur

Идентификаторы

NCT: NCT07573176 · 42847922MDD3011 · 42847922MDD3011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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