A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy
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|ClinicalTrials.gov Identifier: NCT04532749|
Recruitment Status : Terminated (42847922MDD3002 was stopped as a result of the interim analysis (IA) results performed by the Independent Data Monitoring Committee (IDMC))
First Posted : August 31, 2020
Last Update Posted : October 5, 2022
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Seltorexant Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy|
|Actual Study Start Date :||September 15, 2020|
|Actual Primary Completion Date :||May 24, 2022|
|Actual Study Completion Date :||July 14, 2022|
Participants will receive Seltorexant orally once daily from Day 1 to Day 42 (until the end of Week 6).
Participants will receive Seltorexant tablets.
Placebo Comparator: Placebo
Participants will receive matching placebo tablets orally once daily from Day 1 to Day 42 (until the end of Week 6).
Participants will receive matching placebo tablets.
- Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Day 43 [ Time Frame: Baseline to Day 43 ]MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item 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.
- Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score to Day 43 [ Time Frame: Baseline to Day 43 ]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.
- Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score to Day 43 [ Time Frame: Baseline to Day 43 ]The PROMIS-Sleep Disturbance (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 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of 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 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance.
- Change from Baseline in the MADRS-6 Total Score to Day 43 [ Time Frame: Baseline to Day 43 ]The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of 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).
- Percentage of Participants with Response on Depressive Symptoms Scale Based on Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to Day 43 [ Time Frame: Baseline to Day 43 ]Responders are defined as participants with greater than or equal to (>=) 50 percent (%) improvement in the MADRS total score from baseline to Day 43.
- Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score to Day 43 [ Time Frame: Baseline to Day 43 ]The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the diagnostic and statistical manual of mental disorders-5th edition (DSM-5) major depressive disorder (MDD) criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532749
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|