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Seltorexant for Major Depressive Disorder
Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Study Summary
This trial will compare the effectiveness of seltorexant vs quetiapine as an add-on to current antidepressant therapy in people with MDD who have had an inadequate response to an SSRI or SNRI and also have insomnia symptoms.
Eligible Conditions
- Major Depressive Disorder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants with Response (>=50 Percent improvement in MADRS total score from baseline) at Week 26
Secondary outcome measures
Change from Baseline in MADRS-6 Total Score
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Change from Baseline in Patient Health Questionnaire, 9-Item (PHQ-9) Total Score
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SeltorexantExperimental Treatment2 Interventions
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.
Group II: Quetiapine Extended-Release (XR)Active Control2 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Matching placebo to Seltorexant
2020
Completed Phase 3
~760
Seltorexant
2021
Completed Phase 3
~1090
Find a Location
Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,551 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,148 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with major depressive disorder (MDD) without hallucinations or delusions. This diagnosis was made by a doctor using a special interview called SCID-CT. Your first episode of depression occurred before you turned 60 years old, and your current episode of depression has lasted for 24 months or less.You have severe kidney problems, unstable heart or lung conditions, or other significant health issues.You have a history of treatment-resistant depression, which means that you haven't gotten better after trying at least two different antidepressant treatments for at least 6 weeks each, with minimal improvement in your symptoms.You have been diagnosed with or currently have a mental health condition like schizophrenia, bipolar disorder, intellectual disability, autism, borderline personality disorder, or somatoform disorders.You have had a serious problem with drugs or alcohol in the past 6 months.You have sleep disorders like sleep apnea, restless leg syndrome, or parasomnias that significantly affect your sleep quality. However, if you have insomnia disorder, you can still participate.You have tried one or two antidepressant medications, taken for a long enough time and in the right dose, but they did not help enough with your depression symptoms. The current antidepressant cannot be the first one you ever took for depression. An "inadequate response" means your symptoms improved by less than 50%, but you saw some improvement (more than 0%) and had no major side effects, as measured by a questionnaire called the MGH-ATRQ.You have been taking one of the listed medications for depression (like citalopram, duloxetine, escitalopram, etc.) for at least 6 weeks and not longer than 18 months. You should be able to tolerate and benefit from the medication.You have been diagnosed with depression and your depression symptoms have not improved significantly after two evaluations.You have a high score on a sleep assessment called the Insomnia Severity Index (ISI), indicating severe insomnia as reported by both you and the clinician.Your body mass index (BMI) falls between 18 and 40, which means your weight is within a healthy range for your height.
Research Study Groups:
This trial has the following groups:- Group 1: Seltorexant
- Group 2: Quetiapine Extended-Release (XR)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04513912 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there risks often associated with Seltorexant?
"Seltorexant is classified as a Phase 3 medication, so it has received a 3 for safety. This is based on both efficacy data as well as multiple rounds of safety testing."
Answered by AI
How many people are being enlisted for this research project?
"To conduct this study, we need 720 individuals that match the pre-specified inclusion criteria. Fortunately, potential participants can reside near Cary J. Kohlenberg, MD, SC, dba, IPC Research. in Waukesha, Wisconsin or Schuster Medical Research Institute in Sherman Oaks, California."
Answered by AI
Has Seltorexant been studied in any other scientific investigations?
"Seltorexant is currently being trialled in 18 different clinical studies. 4 of those studies have progressed to Phase 3. The majority of trials are based in Bhubaneswar, Orissa; however, there are 598 total locations running these studies."
Answered by AI
If a patient is 55 or younger, do they still qualify for this research program?
"The age requirements to join this trial are patients who are over 18 and below 74 years old."
Answered by AI
What are some of the conditions that Seltorexant is commonly used to treat?
"Seltorexant is most often used to help those suffering from anxiety disorders, although it can also be useful for treating symptoms like mental depression, acute coryza, and bipolar disorder."
Answered by AI
Are there any other places in the world where this research is being conducted?
"This trial is accepting patients at Cary J. Kohlenberg, MD, SC, dba, IPC Research. in Waukesha, Wisconsin, Schuster Medical Research Institute in Sherman Oaks, California, and Fieve Clinical Research, Inc. in New york, New York as well as other sites at 67 other locations."
Answered by AI
Who else is applying?
What state do they live in?
California
Texas
Florida
Other
How old are they?
18 - 65
What site did they apply to?
Proscience Research Group
Bio Behavioral Health
West Houston Clinical Research Service
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
2
3+
Why did patients apply to this trial?
Man. So hard to say. I think this could help me. My antidepressants aren't working.
PatientReceived no prior treatments
I am on an ssri and could do better. Because I am tired of feeling so low.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
When can I start? How long is the screening process? I am taking fluxoamine for OCD and MDD. Also aprozolam for anxiety. Do I still qualify?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Bio Behavioral Health: < 24 hours
- Proscience Research Group: < 48 hours
- West Houston Clinical Research Service: < 48 hours
Average response time
- < 2 Days
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