Recruiting NCT06559306

Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms

Phase III Interventional Depressive Disorder, Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Seltorexant, Placebo, Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI).
Who it may be relevant to: Registry conditions: Depressive Disorder, Major. Basic parameters: 18 years — 74 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Bulgaria, Colombia +11
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Two-Part Multicenter, Double-Blind, Randomized Placebo-Controlled Study to Evaluate Efficacy and Safety and the Maintenance of Effect of 20-(Milligram) mg Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms

Overview

The purpose of this study is to know how well seltorexant works, and also to evaluate safety and maintenance effect of seltorexant compared with placebo as an adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Interventions

Drug Seltorexant
Seltorexant will be administered orally.
Drug Placebo
Matching Placebo tablets will be administered orally.
Drug Selective Serotonin Reuptake Inhibitor (SSRI)/Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
SSRI/SNRI will be administered orally.

Primary outcome measures

Part 1: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 43 [Time frame: Baseline, Day 43]
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Response [Time frame: Time from randomization to the first Relapse during the maintenance phase (up to 2 years and 10 months)]

Secondary outcome measures (12)

Part 1: Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score at Day 43 [Time frame: Baseline, Day 43]
Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a T-score at Day 43 [Time frame: Baseline, Day 43]
Part 1: Change from Baseline in the MADRS-6 Total Score at Day 43 [Time frame: Baseline, Day 43]
Part 1: 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: From Baseline to Day 43]
Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (4a) T-score at Day 43 [Time frame: Baseline, Day 43]
Part 1: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43 [Time frame: Baseline, Day 43]
Part 1: Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score at Day 43 [Time frame: Baseline, Day 43]
Part 2: Time from Randomization to the First Relapse in Participants Who Achieve a Stable Remission [Time frame: Time from randomization to the first relapse during the maintenance phase (up to 2 years and 10 months)]
Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (8a) T-Score [Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)]
Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in Sleep Disturbance Using the PROMIS-SD Short Form (4a) T-Score [Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)]
Part 2: Change from Baseline in Sleep Disturbance Using the Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form (10a) T-score at Day 43 [Time frame: Baseline, Day 43]
Part 2: Change from Baseline to Endpoint of the DB Maintenance Phase in MADRS Total Score [Time frame: From Baseline (Day 1 in the DB treatment maintenance Phase) until end point of the DB maintenance phase (that is up to Day 337)]

Eligibility criteria

Inclusion criteria

Participants in part 1 and direct enrollers to part 2:

Meet DSM-5 MDD, without psychotic features based upon clinical assessment and confirmed by the structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60
Have had an inadequate response to at least 1 but no more than 2 antidepressants, administered at an adequate dose and duration in the current episode of depression. An inadequate response is defined as less than (<) 50% reduction but with some improvement (that is, improvement greater than \[>\] 0%) in depressive symptom severity with residual symptoms other than insomnia present, and overall good tolerability, as assessed by the MGH-ATRQ, and this must include the participant's current antidepressant treatment
Is receiving and tolerating well any one of the following SSRI or SNRI for depressive symptoms at screening, in any formulation and available in the participating country: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline, venlafaxine, desvenlafaxine, vilazodone, or vortioxetine at a stable dose (at therapeutic dose level) for at least 6 weeks
Having a major depressive episode of at least moderate severity, as assessed with 17-item Hamilton Depression Rating Scale, implemented through the Structured Interview Guide (SIGH-D) in a blinded manner at screening and must not demonstrate a clinically significant improvement from the beginning to end of screening.

Participants entering after completing part 1:

Must have completed Part 1 DB treatment phase
Can consistently tolerate study drug (at the end of Part 1), and there is no additional safety risk for the participant if they proceed to Part 2
Was able to consistently follow the study procedures in Part 1 as judged by the investigator.
Must be medically stable based on clinical laboratory tests

Exclusion criteria

Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders and uncontrolled Type 1 or Type 2 diabetes mellitus
Has a history of narcolepsy and seizures
Has current signs/symptoms of hypothyroidism or hyperthyroidism
Participants taking thyroid supplementation for antidepressant purposes
Has Cushing's disease, Addison's disease, primary amenorrhea, or other evidence of significant medical disorders of the HPA axis

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