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Trial · NCT07417813

A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders

NCT07417813, Recruiting, Shanghai Mental Health Center

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders. Trials, record NCT07417813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07417813

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders
NCT number
NCT07417813
Status
Recruiting
Enrollment
121 participants, estimated
Lead sponsor
Shanghai Mental Health Center
Conditions
Insomnia, Psychiatric Disorders
Interventions
Lemborexant tablets
First posted
2026-02-18
Last updated
2026-02-18

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Insomnia Severity Index (ISI) Score from BaselineMeasurement time points: Baseline, Week 4 of treatment, Week 8 of treatmentChange in Insomnia Severity Index (ISI) Score from Baseline: Evaluated by the ISI scale (7 items, total score 0-28 points).
SecondaryISI Treatment Response RateMeasurement time points: Week 4 and Week 8 of treatmentProportion of patients with an ISI score decrease of ≥7 points from baseline.
SecondaryISI Remission RateMeasurement time points: Week 4 and Week 8 of treatmentProportion of patients with an ISI score \<8 points.
SecondaryChange in Sleep Satisfaction VAS ScoreMeasurement time points: Baseline, Week 4 and Week 8 of treatmentIncluding 3 dimensions (sleep onset efficiency, sleep maintenance, impact on daytime function) with 1-10 points for each dimension.
SecondaryChange in Epworth Sleepiness Scale (ESS) ScoreMeasurement time points: Baseline, Week 4 and Week 8 of treatmentChange in Epworth Sleepiness Scale (ESS) Score: Total score 0-24 points.
SecondaryLemborexant Treatment Retention RateWeek 4 and Week 8 of treatmentLemborexant Treatment Retention Rate: Proportion of patients still using lemborexant at Week 4 and Week 8 of treatment;
SecondaryBZRAs Discontinuation RateMeasurement time points: Week 4 and Week 8 of treatmentDiscontinuation rate of patients using BZRAs at baseline
SecondaryBZRAs Dose ChangeMeasurement time points: Week 4 and Week 8 of treatmentChange in diazepam-equivalent dose from baseline

Outcomes0

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.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT07417813

GET https://conductscience.org/api/trials/v1/NCT07417813/registered