A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

  • STATUS
    Recruiting
  • End date
    Dec 26, 2022
  • participants needed
    720
  • sponsor
    Janssen Research & Development, LLC
Updated on 23 November 2020
Investigator
The Medical Research Network, LLC
Primary Contact
Pharmasite Research, Inc. (4.0 mi away) Contact
+165 other location
body mass index
depression
duloxetine
norepinephrine
psychosis
fluvoxamine
psychiatric disorder
antidepressants
scid
depressive symptoms
depressive episode
sertraline
structured clinical interview
selective serotonin reuptake inhibitors
paroxetine
venlafaxine
major depressive disorder
citalopram
quetiapine
fluoxetine
hdrs
vilazodone
vortioxetine
antidepressant therapy
desvenlafaxine
levomilnacipran

Summary

The purpose of this study is to assess the efficacy of seltorexant compared with quetiapine extended-release (XR) as adjunctive therapy to an antidepressant drug in treatment response 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).

Details
Treatment Quetiapine XR, Seltorexant, Matching placebo to Seltorexant, Matching placebo to Quetiapine XR
Clinical Study IdentifierNCT04513912
SponsorJanssen Research & Development, LLC
Last Modified on23 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 74 yrs?
Gender: Male or Female
Do you have Major depression?
Do you have any of these conditions: major depressive disorders or Major depression?
Do you have any of these conditions: Major depression or major depressive disorders?
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 structured clinical interview for DSM-5 Axis I disorders-clinical trials version (SCID-CT) diagnosed with first depressive episode prior to age 60. The length of the current depressive episode must be less than or equal to (<=) 18 months
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. The current antidepressant cannot be the first antidepressant treatment for the first lifetime episode of depression. An inadequate response is defined as less than (<) 50 percent (%) reduction but with some improvement in depressive symptom severity with residual symptoms beyond insomnia present, and overall good tolerability, as assessed by the Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire (MGH-ATRQ)
Is receiving and tolerating well any one of the following selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) for depressive symptoms, 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, and for no greater than 12 months in the current episode, at screening
Have a hamilton depression rating scale (HDRS)-17 total score greater than or equal to (>=) 22 at screening and must not demonstrate a clinically significant improvement (that is, an improvement of greater than [>] 20 percent [%] on their HDRS-17 total score) from the beginning to end of screening, so long as the HDRS-17 total score is >=18 at the end of screening
Have a patient version insomnia severity index (ISI) total score >= 15 as well as a clinician version of the ISI total score >= 15 at the second screening visit
Body mass index (BMI) between 18 and 37 kilogram per meter square (kg/m^2) inclusive (BMI=weight/height^2)
Participant must be medically stable on the basis of the following: physical examination, vital signs (including blood pressure), and 12-lead electrocardiogram (ECG) performed at screening and baseline

Exclusion Criteria

Has a recent (last 3 months) history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance [CrCl] less than [<] 30 milliliter per minute [mL/min]); clinically significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic or endocrine disorders. uncontrolled Type 1 or Type 2 diabetes mellitus
Has a history of treatment-resistant MDD, defined as a lack of response to 2 or more adequate antidepressant treatments in the current episode, as indicated by no or minimal (<25% improvement in symptoms) when treated with an antidepressant of adequate dose (per MGH-ATRQ) and duration (at least 6 weeks)
Has history or current diagnosis of a psychotic disorder, bipolar disorder, intellectual disability, autism spectrum disorder, borderline personality disorder, somatoform disorders, or fibromyalgia
Has a history of moderate to severe substance use disorder including alcohol use disorder according to DSM-5 criteria within 6 months before screening
Has any significant primary sleep disorder, including but not limited to obstructive sleep apnea, restless leg syndrome, or parasomnias. Participants with insomnia disorder are allowed
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