Trial · NCT06843187
Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)
NCT06843187, Phase 2, Terminated, Unity Health Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD). Trials, record NCT06843187. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06843187
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD)
- NCT number
- NCT06843187
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Unity Health Toronto
- Conditions
- Major Depressive Disorder(MDD), Insomnia Comorbid to Psychiatric Disorder
- Interventions
- Lemborexant, Placebo
- First posted
- 2025-02-24
- Last updated
- 2026-07-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility Outcomes | 13 weeks | 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%. |
| Primary | Tolerability Outcomes | 10 weeks | Tolerability will be measured by the frequency and nature of adverse events and medication adherence (i.e., missed dosage). |
| Secondary | Preliminary Clinical Parameters | 6 weeks | 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. |
| Secondary | Within-person Correlations | 10 weeks | 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. |
| Secondary | Standard Deviation | 13 weeks | 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). |
| Secondary | Change in Physiological Biometrics (Oura Ring Metrics) | 13 weeks | 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. |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) | 13 weeks | 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. |
| Secondary | Insomnia Severity Index (ISI-7) | 13 weeks | 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. |
| Secondary | Generalized Anxiety Disorder-7 (GAD-7) | 13 weeks | 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. |
| Secondary | World Health Organization Well-being Index (WHO-5) | 13 weeks | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers33
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06843187
GET https://conductscience.org/api/trials/v1/NCT06843187/papers?page=2