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New treatment option for Major Depressive Disorder(MDD)
Official title Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)
ClinicalTrials.gov ID: NCT06843187
What this study is testing
What is Lemborexant?
Lemborexant is an investigational medicine, given as an once-weekly, being studied as a potential treatment for major depressive disorder(mdd).
Also referred to as Dayvigo.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Have not failed more than 2 trials of antidepressant treatments in the current MDE, and have a history of adequate response (clinical outcome rating...
- 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...
You likely can't join if
- Have taken or participated in any clinical trial of lemborexant and other drugs with the same mechanism (e.g., daridorexant), regardless of treatment...
- 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...
- Women who are pregnant or lactating (documented by a positive beta-human chorionic gonadotropin [beta-hCG] or human chorionic gonadotropin [hCG]...
- Women who are not using an approved and effective method of contraception or family planning during the study. For example, combined estrogen- and...
- Positive toxicology screening results;
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
What rules you out
- 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...
- 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...
- Positive toxicology screening results;
- 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...
- 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...
- 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...
- 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 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...
- Have uncorrected hypothyroidism or hyperthyroidism. people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.