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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04513912




Registration number
NCT04513912
Ethics application status
Date submitted
13/08/2020
Date registered
14/08/2020
Date last updated
13/09/2023

Titles & IDs
Public title
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
Scientific title
Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator 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
Secondary ID [1] 0 0
42847922MDD3005
Secondary ID [2] 0 0
CR108810
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder, Major 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Seltorexant
Treatment: Drugs - Matching placebo to Seltorexant
Treatment: Drugs - Quetiapine XR
Treatment: Drugs - Matching placebo to Quetiapine XR

Experimental: Seltorexant - Adult participants will receive seltorexant once daily from Day 1-7 and together with matching placebo from Day 8 till Day 182. Elderly participants will receive seltorexant once daily from Day 1-3 and together with matching placebo from Day 4 till Day 182.

Active Comparator: Quetiapine Extended-Release (XR) - Adult participants will receive quetiapine XR once daily from Day 1-2, followed by an increase in dose from Day 3-7, and from Day 8-14 together with matching placebo. After Day 14, quetiapine XR twice daily from Day 14 till Day 182. Elderly participants will receive quetiapine XR once daily from Day 1-3 and twice from Day 4-7, followed by an increase in dose once daily from Day 8-14 together with matching placebo. After Day 14 till Day 182, quetiapine XR will be adjusted by investigator based on the participant's clinical response and tolerability.


Treatment: Drugs: Seltorexant
Participants will receive seltorexant over-encapsulated tablet orally.

Treatment: Drugs: Matching placebo to Seltorexant
Participants will receive placebo over-encapsulated tablet matching to seltorexant orally.

Treatment: Drugs: Quetiapine XR
Participants will receive quetiapine XR capsule orally.

Treatment: Drugs: Matching placebo to Quetiapine XR
Participants will receive placebo capsule matching to quetiapine XR orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Response (>=50 Percent improvement in MADRS total score from baseline) at Week 26
Timepoint [1] 0 0
Week 26
Secondary outcome [1] 0 0
Change from baseline in Weight up to Week 26
Timepoint [1] 0 0
Baseline to Week 26
Secondary outcome [2] 0 0
Time to Study Drug Discontinuation for Potentially Treatment Related Reasons
Timepoint [2] 0 0
Up to Week 26
Secondary outcome [3] 0 0
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Timepoint [3] 0 0
Baseline to Week 26
Secondary outcome [4] 0 0
Change from Baseline in MADRS-6 Total Score
Timepoint [4] 0 0
Baseline to Week 26
Secondary outcome [5] 0 0
Change from Baseline in the MADRS Without Sleep Item (MADRS-WOSI) Total Score
Timepoint [5] 0 0
Baseline to Week 26
Secondary outcome [6] 0 0
Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score
Timepoint [6] 0 0
Baseline to Week 26
Secondary outcome [7] 0 0
Percentage of Participants with Remission (MADRS Total Score less than or equal to (<=) 12) at Week 26
Timepoint [7] 0 0
Week 26
Secondary outcome [8] 0 0
Percentage of Participants with a >=50 Percent Improvement in MADRS Total Score and MADRS <=18 at Week 26
Timepoint [8] 0 0
Week 26
Secondary outcome [9] 0 0
Percentage of Participants with Weight Increase >=7 Percent from Baseline at Week 26
Timepoint [9] 0 0
Week 26

Eligibility
Key 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 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 (<=) 24 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 (that is, improvement greater than [>]
0%) in depressive symptom severity with residual symptoms present other than insomnia,
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 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 or above therapeutic dose level) for at least 6
weeks, and for no greater than 18 months in the current episode

- Have a hamilton depression rating scale (HDRS)-17 total score greater than or equal to
(>=) 20 at the first screening interview, must not demonstrate a clinically
significant improvement (that is, an improvement of > 20% on their HDRS-17 total
score) from the first to the second independent HDRS-17 rating, and must have a
HDRS-17 total score >18 at the second screening interview

- 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 40 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
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/10/2023
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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London
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Redruth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04513912
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04513912