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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-74
SponsorJanssen Research & Development, LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 SCID-CT diagnosed with first depressive episode prior to age 55

Experienced at least one MDD episode prior to their current episode based on clinician-confirmed MDD diagnosis/MDE and documented in source records

Current episode of MDD must be a minimum of 8 weeks in duration and maximum of 24 months duration

Must meet one of the following criteria regarding current medication status.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Seltorexant

    Drug

    Seltorexant tablet will be administered orally.

  • Placebo

    Drug

    Placebo tablet will be administered orally.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: SeltorexantExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.

Time frame
Baseline up to Day 43
2

Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs)

An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. The following AESIs are considered in this study: Suicidal thoughts, suicidal ideation, and suicidal behavior; Cataplexy; Sleep paralysis; Complex, sleep-related behaviors/parasomnias; Fall and Motor vehicle accident.

Time frame
OL Baseline (Day 43) Up to 6 months
3

OL Treatment Phase: Number of Participants with Vital Signs Abnormalities

Number of participants with vital signs (blood pressure and pulse/heart rate measurements) abnormalities will be reported.

Time frame
OL Baseline (Day 43) Up to 6 months
4

OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS)

The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.

Time frame
OL Baseline (Day 43) Up to 6 months

Secondary outcomes

1

DB Treatment Phase: Change from Baseline in MADRS-Without Sleep Item (WOSI) Total Score

MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity.

Time frame
Baseline up to Day 43
2

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

The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance.

Time frame
Baseline up to Day 43
3

DB Treatment phase: Change from Baseline in MADRS-6 Total Score

The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of major depressive disorder (MDD) symptoms. The MADRS-6 scale is a subset of the MADRS -10 scale, comprised of the following individual questionnaire items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms).

Time frame
Baseline up to Day 43
4

DB Treatment Phase: Proportion of Participants with Response on Depressive Symptoms Scale

Responders are defined as proportion of participants with greater than or equal to (\>=) 50 percent (%) improvement in the MADRS total score from baseline to Day 43.

Time frame
Baseline up to Day 43

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.