NCT06843187

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

Lemborexant for the Treatment of Residual Insomnia in Adequately Treated Major Depressive Disorder: a Pilot Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed description

Major Depressive Disorder (MDD) is often accompanied by persistent residual insomnia which does not resolve, even after adequate MDD treatment. Lemborexant is an orexin receptor antagonist involved in the regulation of sleep-wake cycles with a favourable safety profile compared to other sleep medications. There are currently no trials evaluating the feasibility and clinical efficacy of Lemborexant as a treatment for residual insomnia in patients with adequately treated MDD. This pilot study will investigate the feasibility, tolerability, and efficacy of Lemborexant in adults with adequately-treated MDD and residual insomnia.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2025-02-24
• Last updated: 2025-02-24

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study