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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• 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) [Time frame: Baseline up to Day 43]
• Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs) [Time frame: OL Baseline (Day 43) Up to 6 months]
• OL Treatment Phase: Number of Participants with Vital Signs Abnormalities [Time frame: 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) [Time frame: OL Baseline (Day 43) Up to 6 months]
• OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20) [Time frame: 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) [Time frame: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX) [Time frame: Up to 6 months]
• OL Treatment Phase: Change from Baseline in the Body Weight [Time frame: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI) [Time frame: OL Baseline (Day 43) up to 6 months]
• OL Treatment Phase: Change from Baseline in the Waist Circumference [Time frame: OL Baseline (Day 43) up to 6 months]

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 26 centers

• 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
• … and 18 more centers

Taiwan · 2 centers

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

Brazil · 1 center

• Centro Integrado Facili — São Bernardo do Campo

Malaysia · 1 center

• University Malaya Medical Centre — Kuala Lumpur

Identifiers

NCT: NCT07573176 · 42847922MDD3011 · 42847922MDD3011

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗