Actively Recruiting
Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)
Led by Unity Health Toronto · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
U
Unity Health Toronto
Lead Sponsor
U
University of Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Lemborexant works to treat residual insomnia in adults with depression that is being treated. It will also learn about how practical, tolerable, and effective Lemborexant is. The main questions it aims to answer are: * Does Lemborexant help participants improve sleep and reduce insomnia symptoms? * How practical is it to use Lemborexant (how many participants join, drop out, and follow the study rules)? How do participants feel about using it (based on surveys and interviews)? Researchers will compare Lemborexant to a placebo (a look-alike substance that contains no drug) to see if Lemborexant works to treat residual insomnia in adequately treated major depressive disorder. Participants will: * Take Lemborexant or a placebo every day for 6 weeks (2 weeks at 5 mg then 4 weeks at 10 mg) * Complete clinical assessments and in-person study visits * Maintain a digital sleep diary and complete daily and weekly self-report ecological momentary assessments (EMAs) * Use a wearable device which will be used to collect and monitor physiological data
CONDITIONS
Official Title
Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years with a body mass index (BMI) between 19 and 30 kg/m2
- Diagnosed with primary Major Depressive Disorder (MDD) without psychotic symptoms and currently in a major depressive episode
- Have not failed more than 2 antidepressant treatments during the current episode and have responded adequately to at least 1 antidepressant treatment
- Are outpatients
- Have not taken non-psychotropic or non-central nervous system medications affecting sleep for at least 4 weeks before the study
- Self-report total sleep time of 6.5 hours or less, sleep onset latency of 30 minutes or more, and wake after sleep onset of 45 minutes or more per night
- Spend between 7 and 10 hours in bed per night, with a regular bedtime between 9:00 PM and 1:00 AM and wake time between 5:00 AM and 10:00 AM
- Confirm insomnia symptoms from sleep diary on at least 5 of 7 consecutive mornings
- Confirm regular bedtime and wake time on at least 5 of the 7 preceding nights
- Have a medically responsible physician during the trial
- Have a current Hamilton Depression Rating Scale (HAM-D-17) score of 8 or higher and an insomnia severity index score of 15 or higher
- Are able to understand and comply with study requirements
- Provide written informed consent
- Own a smartphone with reliable internet access to complete questionnaires
You will not qualify if you...
- Previous participation in trials of lemborexant or similar drugs
- Known sensitivity to lemborexant or its ingredients
- History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic symptoms
- Pregnant or breastfeeding women
- Women not using approved and effective contraception during the study
- Positive toxicology screening
- Unstable psychotherapy treatment or anticipated changes in therapy during the study
- Active suicidal intent
- Recent electroconvulsive therapy or intravenous ketamine therapy
- Insomnia caused by other sleep disorders or conditions impacting sleep
- High risk for sleep apnea or restless legs syndrome
- Habitual late afternoon or evening naps 4 or more days a week
- Recent or planned travel across more than 3 time zones
- Recent insomnia treatment including cognitive-behavioral therapy
- Excessive caffeine or alcohol consumption
- Use of prohibited medications or sleep aids prior to screening
- History of sleep-related violent or complex behaviors
- Recent substance dependence or abuse
- Unstable major medical illness or certain neurological conditions
- Risk factors for heart arrhythmias or prolonged QT interval
- Scheduled major surgery during the study
- Clinical instability that could be worsened by study medication
- Uncorrected thyroid disorders
- Any condition that may affect ability to complete the study
- Non-English speakers due to communication requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
Research Team
V
Venkat Bhat, MD, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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