Lemborexant for Insomnia and Depression
(MDD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Lemborexant, a medication, can alleviate sleep problems in individuals receiving treatment for depression. The researchers seek to discover whether this medication can enhance sleep quality and reduce insomnia symptoms. Participants will take either Lemborexant or a placebo (a non-active look-alike) for six weeks to assess any differences. Suitable candidates have depression, are already undergoing treatment, and continue to experience sleep difficulties. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you keep any current psychiatric medications unchanged for 4 weeks before screening and throughout the study. Additionally, you must not have taken any medications affecting sleep-wake function for at least 4 weeks before starting the study.
Is there any evidence suggesting that Lemborexant is likely to be safe for humans?
Research has shown that lemborexant is generally safe for people with insomnia. Some studies found common side effects such as sleepiness, fatigue, dizziness, or nausea. Importantly, lemborexant has not been associated with worsened sleep after discontinuation or withdrawal symptoms.
For individuals with depression or anxiety, studies found that lemborexant improved sleep without introducing new safety concerns. Although some reported nightmares or unusual dreams, these occurrences were uncommon.
Overall, lemborexant appears to be a safe option for managing insomnia, even for those also experiencing depression.12345Why do researchers think this study treatment might be promising?
Lemborexant is unique because it targets insomnia and depression by acting on the orexin receptors in the brain. Unlike traditional treatments that often focus on serotonin or dopamine pathways, lemborexant works by blocking orexin, a chemical involved in wakefulness, potentially offering a new approach to both sleep disorders and mood improvement. Researchers are excited about its potential to provide relief with fewer side effects and its promise in managing two conditions simultaneously with a single treatment.
What evidence suggests that Lemborexant might be an effective treatment for insomnia in depression?
Research has shown that Lemborexant, which participants in this trial may receive, helps people with insomnia sleep better. Studies have found that it reduces the time spent awake after falling asleep and improves overall sleep quality. It works well for individuals with insomnia who also experience depression or anxiety. Lemborexant is considered more effective than other insomnia treatments and is generally safe, typically not causing unexpected side effects. Overall, Lemborexant presents a promising option for improving sleep in people with insomnia.12467
Who Is on the Research Team?
Venkat Bhat, MD, MSc
Principal Investigator
Unity Health Toronto
Are You a Good Fit for This Trial?
Adults with major depressive disorder (MDD) who are currently being treated but still experience insomnia can join this trial. They must be willing to take a daily pill, maintain a sleep diary, wear a monitoring device, and attend study visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take Lemborexant or placebo daily for 6 weeks, with clinical assessments and in-person visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lemborexant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor
Toronto Metropolitan University
Collaborator
University of Toronto
Collaborator
Centre for Addiction and Mental Health
Collaborator