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New sleep aid studied for those with mental illness

NCT ID NCT07417813

Symptom relief Sponsor: Shanghai Mental Health Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well and how safely a new sleep medication, lemborexant, works for people who have both a mental health condition and trouble sleeping. About 121 adults will take the drug for 8 weeks, and researchers will track changes in their sleep quality and any side effects. The goal is to find better ways to treat insomnia in people with psychiatric disorders.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 121 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults ≥18 years with any DSM-5-diagnosed mental disorder, ISI score ≥11, ≥7 hours available sleep time, ability to complete 2-month assessments/follow-up, voluntary informed consent, and clinical indication for lemborexant treatment.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 years and above, regardless of gender; 2. Meet the DSM-5 diagnostic criteria for mental disorders (any type); 3. Insomnia Severity Index (ISI) score ≥11; 4. Have at least 7 hours of sleep time available; 5. Able to complete the 2-month scale assessment and follow-up plan; 6. Voluntarily sign the informed consent form; 7. Intend to receive lemborexant treatment as judged by the clinicians Exclusion Criteria: 1. Mental disorder is in the acute phase as judged by clinical assessment, or the dose of other psychotropic drugs cannot be stabilized during the study; 2. Concurrent use of ≥2 types of benzodiazepine receptor agonists (BZRAs) as insomnia treatment drugs; 3. Previous continuous use of dual orexin receptor antagonist (DORA)-type drugs for \>1 week; 4. Clear suicide attempt/plan or high suicide risk as judged by the researcher; 5. Pregnant or lactating women; 6. Patients with narcolepsy; 7. Patients with severe hepatic insufficiency; 8. Currently accompanied by severe or unstable diseases of cardiovascular, respiratory, digestive and other systems; 9. Other conditions deemed unsuitable for participation by the researcher

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Conditions

The condition(s) this trial relates to.

insomnia psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Psychiatric disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • Shanghai Fengxian District Mental Health Center

    RECRUITING

    Shanghai, Shanghai Municipality, 201400, China

  • Shanghai Mental Health Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Pudong New Area Mental Health Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200120, China

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Suzhou GuangJi Hospital

    RECRUITING

    Suzhou, Jiangsu, 215000, China

  • The First Affiliated Hospital of Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315000, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • Xuzhou Oriental People's Hospital

    RECRUITING

    Xuzhou, Jiangsu, 221000, China

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