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Major Depressive Disorder(MDD)Phase 2MDDNCT06843187

Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)

A Phase 2 study testing Lemborexant in people with Major Depressive Disorder(MDD) and Insomnia Comorbid to Psychiatric Disorder, run by Unity Health Toronto at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Lemborexant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteCanada
Study dates
25 Sep 2024to 15 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 70 (inclusive), with a self-reported body mass index (BMI) between 19 and 30 kg/m2 (inclusive);
  • Meet criteria for primary MDD diagnosis without psychotic symptoms, as defined by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)2, and currently in a MDE, confirmed by the MINI International Neuropsychiatric Interview (MINI)3;
  • Have not failed more than 2 trials of antidepressant treatments in the current MDE, and have a history of adequate response (clinical outcome rating score of 1 or 2) to at least 1 antidepressant treatment during the current MDE as determined by the Antidepressant Treatment History Form-Short Form (ATHF-SF)4;
  • Are outpatients;
  • Did not take non-psychotropic or non-central nervous system (CNS) medications suspected to affect sleep-wake function for at least 4 weeks before starting the study.
  • Self-reported subjective total sleep time (sTST) ≤ 6.5 hours, subjective sleep onset latency (sSOL) ≥ 30 minutes, and subjective wake after sleep onset (sWASO) ≥ 45 minutes per night. Time spent in bed (either sleeping or attempting to sleep) must be between 7 and 10 hours per night. Self-reported regular bedtime (i.e., the time the participant gets in bed) between 21:00 and 01:00 and regular wake time (i.e., the time the participant wakes and does not go back to sleep) between 05:00 and 10:00;
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  • Confirmation of current insomnia symptoms as determined from responses on the Sleep Diary completed on at least 7 consecutive mornings (minimum 5 of 7 for eligibility), such that sSOL ≥ 30 minutes on at least 3 of the 7 nights and/or sWASO ≥ 45 minutes on at least 3 of the 7 nights;
  • Confirmation of sufficient duration of time spent in bed, as determined from responses on the Sleep Diary on the 7 most recent mornings before the visit, such that there are no more than 2 nights with time spent in bed of duration < 7 hours or > 10 hours;
  • Confirmation of regular bedtime (i.e., the time the participant gets in bed) between 21:00 and 01:00 on at least 5 of the 7 preceding nights, and regular wake time (i.e., the time the participant wakes and does not go back to sleep) between 05:00 and 10:00 on at least 5 of the 7 preceding nights.
  • Have a medically responsible physician (family doctor or psychiatrist) during their enrollment and participation in the trial;
  • Current 17-Item Hamilton Depression Rating Scale (HAM-D-17)30 score ≥ 8 and reporting an insomnia score of ≥15 on ISI1;
  • Are able to understand and comply with the requirements of the study, as judged by the investigator(s);
  • Provide written informed consent before initiation of any study-related procedures;
  • Own a smartphone and have reliable access to the internet and a browser on which to complete questionnaires.

Who cannot join

  • Have taken or participated in any clinical trial of lemborexant and other drugs with the same mechanism (e.g., daridorexant), regardless of treatment outcome;
  • Have any known sensitivity to lemborexant or their excipients;
  • A lifetime history (current or previous) of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychotic symptoms as determined by the MINI;
  • Women who are pregnant or lactating (documented by a positive beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG] urine test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG or hCG);
  • Women who are not using an approved and effective method of contraception or family planning during the study. For example, combined estrogen- and progestogen-containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and ligation, vasectomized partner, sexual abstinence, or two forms of contraception with any barrier method or oral hormones (ie.g., condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).
  • Positive toxicology screening results;
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  • If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions or the therapeutic focus 4 weeks before screening and the entire duration of participation;
  • Have active suicidal intent as determined by a score of 3 (severe suicidality with a clear plan and/or intent) or 4 (very severe: suicidal attempts) on item #3 on the HAM-D-17;
  • Have had a course of electroconvulsive therapy or intravenous ketamine therapy in the current episode or any previous episode;
  • Medical history of insomnia associated with another sleep disorder or any condition known to impact sleep. This includes any lifetime diagnosis of sleep-related breathing disorder, periodic limb movement disorder, restless legs syndrome, nightmare disorder, sleep terror disorder, sleepwalking disorder, rapid eye movement (REM) behaviour disorder, narcolepsy, or comorbid nocturia that is causing or exacerbating insomnia;
  • STOP-Bang5 scores ≥ 5; International Restless Legs Scale (IRLS)6 scores ≥ 16,Epworth Sleepiness Scale (ESS)⁷ ≥ 11
  • Habitual naps 4 or more days a week, occurring in the late afternoon or evening;
  • Transmeridian travel across more than 3 time zones in the 2 weeks before screening, or between screening and study baseline, or plans to travel across more than 3 time zones during the study;
  • Used any modality of treatment for insomnia, including cognitive-behavioural therapy within 2 weeks before screening;
  • Excessive caffeine use, defined as consuming more than 400 mg of caffeine per day (approximately 4 cups of brewed coffee), or habitual consumption of caffeine after 6:00 p.m., which in the investigator's opinion may contribute to insomnia;
  • Reports habitually consuming more than 14 drinks containing alcohol per week (females) or more than 21 drinks containing alcohol per week (males);
  • Used prohibited prescriptions or over-the-counter concomitant medications, or used any medication or sleep aid with known effects on sleep within 2 weeks before screening;
  • Report a history of sleep-related violent behaviour, or sleep driving, or any other complex sleep-related behaviour (e.g., making phone calls, preparing and eating food);
  • Diagnosis of substance dependence or abuse within the last 3 months as determined by MINI3;
  • Have a concomitant major unstable medical illness, cardiac pacemaker, or implanted medication pump;
  • Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes;
  • A history of risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or the use of concomitant medications that prolonged the QTcF interval;
  • Scheduled for major surgery during the study;
  • Have a clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus, hypertension, unstable angina);
  • Have uncorrected hypothyroidism or hyperthyroidism. Subjects needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for 30 days prior to enrolment;
  • Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measures.
  • Non-English-speaking individuals because the ability to communicate study information, answer questions accurately and completely about the study, and obtain consent are necessary.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hospital, Unity Health Toronto

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: Lemborexant for the Treatment of Residual Insomnia in Adequately Treated Major Depressive Disorder: A Pilot Randomized Controlled Trial

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)?
Read more

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
Read the detailed description

Major Depressive Disorder (MDD) is often accompanied by persistent residual insomnia which does not resolve, even after adequate MDD treatment. Lemborexant is an orexin receptor antagonist involved in the regulation of sleep-wake cycles with a favourable safety profile compared to other sleep medications. There are currently no trials evaluating the feasibility and clinical efficacy of Lemborexant as a treatment for residual insomnia in patients with adequately treated MDD. This pilot study will investigate the feasibility, tolerability, and efficacy of Lemborexant in adults with adequately-treated MDD and residual insomnia.

Being tested
Lemborexant, Placebo
Keywords
Lemborexant, Residual Insomnia, Major depressive disorder (MDD), Ecological momentary assessments (EMA), Wearable devices, Remote measurement-based care, Randomized controlled trial, Digital health monitoring, Feasibility trial, Pilot study, Placebo-controlled
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LemborexantDrug

    Also called Dayvigo

    Dayvigo (lemborexant compound) is an orexin antagonist that acts on the arousal and sleep neural networks of the brain to regulate sleep-wake cycles and is used in the treatment of insomnia characterized by difficulties with sleep.

  • PlaceboOther

    The placebo is an inactive sugar pill that looks and tastes identical to the lemborexant pill.

Study groups in NCT06843187
Study groupRoleWhat they receive
LemborexantExperimentalParticipants will take a 5 mg pill of lemborexant daily for two weeks, followed by a dosage increase to 10 mg daily for the next four weeks (6 weeks total).
Receives: Drug: Lemborexant
PlaceboPlacebo comparatorParticipants will take a 5 mg of placebo pill daily for 2 weeks then 10 mg daily for 4 weeks (total of 6 weeks).
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility Outcomes

    Feasibility will be measured by the recruitment rate, withdrawal rate, data completion rate, and adherence rate. Recruitment rate will be quantified by the percentage of eligible participants enrolled relative to the number of participants contacted. Feasibility will be marked as a minimum of 1-2 participants enrolled per month. Withdrawal/dropout rate will be quantified by the percentage of participants who drop out of the study. The upper limit of the 95% confidence interval (CI) for dropout rate should not exceed 20%.

    Adherence and data completion will bhe proportion of participants who strictly follow the study protocol (the "per-protocol group") will be estimated with a 95% CI. This includes adherence to treatment (taking the medication correctly for six weeks), study completion (attending all required visits), and providing complete data. To be considered feasible, the lower limit of this 95% CI must be greater than 80%.

    Measured: 13 weeks

  2. Tolerability Outcomes

    Tolerability will be measured by the frequency and nature of adverse events and medication adherence (i.e., missed dosage).

    Measured: 10 weeks

Secondary outcomes (9)

  1. Preliminary Clinical Parameters

    Changes in insomnia symptoms will be measured using the Insomnia Severity Index (ISI) Score. ISI score reduction will be compared between allocation and treatment end for participants randomized to receive Lemborexant and those receiving placebo.

    Measured: 6 weeks

  2. Within-person Correlations

    Within-person changes in insomnia symptoms will be measured by within-person correlations of baseline and follow-up ISI scores. The ISI assesses the severity of insomnia symptoms, such as the impact of sleep on daytime functioning, difficulties with sleep onset, and sleep maintenance. Each item is rated on a scale from 0 (mild) to 4 (very severe), with a higher overall score indicating more severe insomnia presentations.

    Measured: 10 weeks

  3. Standard Deviation

    Within and between participant variability in insomnia symptoms will be measured by standard deviation of ISI scores. This measure will be separate for each group (treatment and placebo).

    Measured: 13 weeks

  4. Change in Physiological Biometrics (Oura Ring Metrics)

    Physiological biometrics will be captured using the Oura Ring and analyzed as a composite measure of changes across multiple parameters. Individual metrics will be reported separately and summarized as part of an overall physiological profile. The measured parameters include daily activity (step count (steps/day) and energy expenditure (METs)), heart rate metrics (resting heart rate (beats per minute) and heart rate variability (milliseconds)), body temperature (average nightly body temperature deviation (degrees Celsius), sleep quality (sleep latency, total time in bed, sleep staging (light, deep, REM sleep in minutes)), wake onset (minutes), and Oura composite scores (sleep, activity, and readiness scores (0-100 scale)). Statistical analyses will assess changes in each metric individually, as well as aggregated trends across sleep, activity, and recovery domains.

    Measured: 13 weeks

  5. Patient Health Questionnaire-9 (PHQ-9)

    This questionnaire assesses the severity of depression, with questions probing the frequency and severity of symptoms such as mood, energy, sleep, and concentration. Each item is scored from 0 (not at all) to 3 (nearly every day), with a higher total score indicating more severe depression presentations.

    Measured: 13 weeks

  6. Insomnia Severity Index (ISI-7)

    This questionnaire assesses the severity of insomnia symptoms, such as the impact of sleep on daytime functioning, difficulties with sleep onset, and sleep maintenance. Each item is rated on a scale from 0 (mild) to 4 (very severe), with a higher overall score indicating more severe insomnia presentations.

    Measured: 13 weeks

  7. Generalized Anxiety Disorder-7 (GAD-7)

    This questionnaire assesses the severity of anxiety symptoms, such as excessive worry, restlessness, and irritability. Each question is scored ranging from 0 (not at all) to 3 (nearly every day), with a higher overall score indicating more severe presentations of anxiety.

    Measured: 13 weeks

  8. World Health Organization Well-being Index (WHO-5)

    This questionnaire is a self-report measure that evaluates subjective well-being, with statements probing mood, vitality, and mental well-being. Participants rate their responses from 0 (at no time) to 5 (all the time), with a higher overall score indicating positive well-being.

    Measured: 13 weeks

  9. Montgomery-Åsberg Depression Rating Scale (MADRS)

    This clinician-administered scale assesses the severity and changes in depression symptoms over time. Each item is rated from 0 (no symptoms) to 6 (very severe symptoms), with a higher overall score indicating more severe depression.

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start25 Sep 2024
  3. Primary completion15 Jul 2026
  4. Study completion15 Jul 2026

Why it stopped: Funding withdrawn by sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blind, randomized placebo-controlled pilot trial will be conducted with 30 adults with MDD and residual insomnia. Participants will be randomized to one of two intervention arms (2:1 allocation): lemborexant (experimental group; n = 20) or placebo (control group; n = 10). There will be a 3-week baseline period prior to the 6-week intervention period (lemborexant or a placebo pill for 2 weeks at 5 mg then 4 weeks at 10 mg) and 4-week follow-up period with weekly clinical assessments. Participants will complete a daily digital sleep diary and frequent EMAs on a web-based survey platform as well as passive digital health monitoring via a wearable device. Semi-structured exit interviews will be completed at the end of the study.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06843187
Sponsor's protocol ID
24-133
Other IDs
68425v4
Acronym
MDD
Status last verified
Mar 2026
First submitted
21 Jan 2025
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Manual (on) Transcription: Transcription Conventions, Software Guides and Practical Hints for Qualitative Researchers. 3. Engl. Ed., January 2015. Marburg: dr. dresing et pehl GmbH; 2015.

  • Wilson EB. Probable Inference, the Law of Succession, and Statistical Inference. J Am Stat Assoc. 1927;22: 209-212. doi:10.1080/01621459.1927.10502953

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PubMed 25831962

  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171

  • Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

    PubMed 10568646

  • Bang H, Flaherty SP, Kolahi J, Park J. Blinding assessment in clinical trials: A review of statistical methods and a proposal of blinding assessment protocol. Clin Res Regul Aff. 2010;27: 42-51. doi:10.3109/10601331003777444

  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PubMed 18929686

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PubMed 9881538

  • HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

    PubMed 14399272

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246

  • Edward KL, Garvey L, Aziz Rahman M. Wearable activity trackers and health awareness: Nursing implications. Int J Nurs Sci. 2020 Mar 25;7(2):179-183. doi: 10.1016/j.ijnss.2020.03.006. eCollection 2020 Apr 10.

    PubMed 32685614

  • Lee S, Kim H, Park MJ, Jeon HJ. Current Advances in Wearable Devices and Their Sensors in Patients With Depression. Front Psychiatry. 2021 Jun 17;12:672347. doi: 10.3389/fpsyt.2021.672347. eCollection 2021.

    PubMed 34220580

  • Ahmed A, Aziz S, Alzubaidi M, Schneider J, Irshaidat S, Abu Serhan H, Abd-Alrazaq AA, Solaiman B, Househ M. Wearable devices for anxiety & depression: A scoping review. Comput Methods Programs Biomed Update. 2023;3:100095. doi: 10.1016/j.cmpbup.2023.100095. Epub 2023 Jan 30.

    PubMed 36743720

  • Martin J, Rueda A, Lee GH, Tassone VK, Park H, Ivanov M, Darnell BC, Beavers L, Campbell DM, Nguyen B, Torres A, Jung H, Lou W, Nazarov A, Ashbaugh A, Kapralos B, Litz B, Jetly R, Dubrowski A, Strudwick G, Krishnan S, Bhat V. Digital Interventions to Understand and Mitigate Stress Response: Protocol for Process and Content Evaluation of a Cohort Study. JMIR Res Protoc. 2024 May 6;13:e54180. doi: 10.2196/54180.

    PubMed 38709554

  • Eisai Inc. PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: DAYVIGO Lemborexant Tablet Tablet, 5 mg, 10 mg, Oral. 2023.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lemborexant in people with Major Depressive Disorder(MDD) and Insomnia Comorbid to Psychiatric Disorder, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding withdrawn by sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Outcomes (time frame: 13 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06843187, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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