Seltorexant for Major Depressive Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of seltorexant as an additional treatment for individuals with major depressive disorder who also experience sleep difficulties and have not fully improved with their current antidepressant. It compares seltorexant with a placebo (a pill with no active medicine) to determine which better alleviates depression symptoms. The trial seeks participants who have been on an SSRI or SNRI (types of antidepressants) for at least six weeks but still experience significant symptoms. Participants should have undergone a major depressive episode without complete relief from their current medication and have symptoms like insomnia. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. The trial is designed for people who are already taking an SSRI or SNRI antidepressant and have not had a full response to it.
Is there any evidence suggesting that seltorexant is likely to be safe for humans?
Research has shown that seltorexant is generally safe and well-tolerated. Studies have found it to have a good safety record in people with major depressive disorder (MDD). The common side effects align with those observed in other seltorexant studies. For instance, one study found that patients handled seltorexant well, with side effects matching those from earlier trials. This consistency in side effects can reassure participants. Additionally, seltorexant has been tested in both adults and teenagers, showing similar safety results. These findings suggest that seltorexant is a promising treatment option with a good safety profile.12345
Why do researchers think this study treatment might be promising for major depressive disorder?
Researchers are excited about seltorexant for treating major depressive disorder because it works differently from many traditional antidepressants like SSRIs and SNRIs. Seltorexant targets the orexin system, which plays a role in regulating mood and sleep, offering a new approach to managing depression symptoms. This novel mechanism of action could provide benefits for patients who haven't responded well to current treatments, potentially leading to faster and more effective relief.
What evidence suggests that seltorexant might be an effective treatment for major depressive disorder with insomnia symptoms?
Research has shown that seltorexant can improve symptoms of depression, particularly for individuals with major depressive disorder who struggle with sleep. In this trial, participants in Part 1 will receive either seltorexant or a placebo, in addition to their baseline SSRI/SNRI antidepressant. One study demonstrated that patients taking seltorexant with an antidepressant experienced greater improvements in depression than those taking quetiapine XR. Another study found seltorexant more effective in reducing depression severity for patients with severe insomnia at the start. Additionally, seltorexant has improved sleep quality, offering significant benefits for those whose depression affects their sleep. Overall, seltorexant appears promising for individuals dealing with both depression and insomnia.24678
Are You a Good Fit for This Trial?
Adults and elderly with major depressive disorder (MDD) who also have insomnia symptoms, and haven't fully responded to SSRI or SNRI antidepressants. Participants must be stable on their current antidepressant for a certain period before joining.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive seltorexant or placebo orally once daily for 6 weeks during the double-blind treatment phase
Follow-up Part 1
Participants who do not proceed to Part 2 undergo a post-treatment follow-up phase
Open-label Phase Part 2
All participants who complete Part 1 and meet eligibility criteria for Part 2 receive seltorexant orally in addition to their background SSRI/SNRI treatment
Double-blind Maintenance Phase Part 2
Participants who achieve a stable response during the open-label phase receive treatment with seltorexant or placebo orally once daily
What Are the Treatments Tested in This Trial?
Interventions
- Seltorexant
Trial Overview
The trial is testing Seltorexant as an additional treatment alongside existing SSRI/SNRI therapy compared to a placebo. It aims to see if Seltorexant improves depression and sleep in those not fully helped by their current medication.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. In Part 2 open-label phases (induction and stabilization) all participants (newly enrolled direct entry participants and Part 1 roll-over participants) will receive seltorexant orally in addition to their background SSRI/SNRI treatment.
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phase will receive treatment with seltorexant orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
Participants will receive seltorexant orally once daily for 6 weeks during the double-blind (DB) treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant throughout the study.
Participants will receive matching placebo orally once daily for 6 weeks during the DB treatment phase in Part 1 of the study. Participants who do not proceed to Part 2 of the study will undergo a post-treatment follow-up phase, after the DB treatment phase in Part 1 and will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
All participants who complete Part 1, and who meet eligibility criteria for Part 2, as well as direct entry participants, will enter Part 2 of the study. Participants who achieve a stable response during the open-label phases will receive treatment with matching placebo orally once daily during DB Maintenance Phase in Part 2 of the study. Participants will continue to take their single baseline SSRI/SNRI antidepressant throughout the study.
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Citations
Treatment effect and safety of seltorexant as monotherapy ...
Improvement in depression severity at week 5 for seltorexant 20 mg was greater in patients with higher baseline insomnia severity (nominal p = ...
Seltorexant, in combination with an oral antidepressant ...
Seltorexant and quetiapine XR showed large and clinically meaningful improvements in depressive symptoms (-23.0 and -22.7, respectively), as ...
Efficacy of orexin antagonists for the management of major ...
Results showed that seltorexant, at a single dose of 40 mg, led to a non-significant decrease in depressive symptoms compared to placebo.
Efficacy and Safety of Seltorexant in Insomnia Disorder
On day 14, compared with zolpidem, seltorexant, 10 mg and 20 mg, showed greater improvements in subjective sleep onset latency and subjective ...
5.
jnjmedicalconnect.com
jnjmedicalconnect.com/media/attestation/congresses/neuroscience/2024/psych/adjunctive-treatment-with-seltorexant-improved-patientreported-depressive-symptoms-insomnia-symptoms.pdfAdjunctive treatment with seltorexant improved patient- ...
From the patient's perspective, adjunctive treatment with seltorexant improved depressive symptoms, sleep disturbances and overall health, ...
Treatment effect and safety of seltorexant as monotherapy ...
Seltorexant was well tolerated and showed a good safety and tolerability profile in MDD patients. The incidence of TEAEs in the 20 mg ...
Seltorexant for major depressive disorder
Expert opinion: Early clinical evidence suggests that seltorexant is effective in treating MDD, both in individuals diagnosed with insomnia and ...
8.
psychiatrictimes.com
psychiatrictimes.com/view/seltorexant-well-tolerated-in-adolescents-as-an-adjunct-treatment-for-major-depressive-disorderSeltorexant Well-Tolerated in Adolescents as an Adjunct ...
Seltorexant showed a favorable safety profile and similar pharmacokinetics in adolescents compared to adults in a phase 1b study. The study ...
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