Lemborexant for Insomnia and Depression
(MDD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byVenkat Bhat, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Unity Health Toronto

Prior Safety Data

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

Adults with major depressive disorder (MDD) who are currently being treated but still experience insomnia can join this trial. They must be willing to take a daily pill, maintain a sleep diary, wear a monitoring device, and attend study visits.

Inclusion Criteria

Meet specific sleep criteria at screening visits 1 and 2

Own a smartphone and have reliable internet access

Provide written informed consent

+6 more

Exclusion Criteria

Previously participated in any clinical trial of lemborexant

Have known sensitivity to lemborexant or its excipients

I am not using any birth control methods approved by this study.

+24 more

Participant Groups

The trial is testing Lemborexant against a placebo to see if it improves sleep in people with depression-related insomnia. Participants will start with a lower dose for 2 weeks and then increase the dose for another 4 weeks while their experiences are monitored.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LemborexantExperimental Treatment1 Intervention

Participants will take a 5 mg pill of lemborexant daily for two weeks, followed by a dosage increase to 10 mg daily for the next four weeks (6 weeks total).

Group II: PlaceboPlacebo Group1 Intervention

Participants will take a 5 mg of placebo pill daily for 2 weeks then 10 mg daily for 4 weeks (total of 6 weeks).