MedTrace Logo

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

NCT06843187 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-08

No results posted yet for this study

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. 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)?

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

Conditions

  • Major Depressive Disorder(MDD)
  • Insomnia Comorbid to Psychiatric Disorder

Interventions

DRUG

Lemborexant

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • Toronto Metropolitan University

    collaborator OTHER

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Venkat Bhat, MD, MSc · Unity Health Toronto

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-25
Primary Completion
2027-12-31
Completion
2028-04-30
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843187 on ClinicalTrials.gov