Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06843187 | Lemborexant for the Treatment of Residual Insomnia in Major Depressive Disorder (MDD) | PHASE2 | RECRUITING | 30 | — | — | Sep 25, 2024 | Apr 1, 2028 | May 8, 2026 | 1 | Canada |
Feasibility will be measured by the recruitment rate, withdrawal rate, data completion rate, and adherence rate. Recruitment rate will be quantified by the percentage of eligible participants enrolled relative to the number of participants contacted. Feasibility will be marked as a minimum of 1-2 participants enrolled per month. Withdrawal/dropout rate will be quantified by the percentage of participants who drop out of the study. The upper limit of the 95% confidence interval (CI) for dropout rate should not exceed 20%. Adherence and data completion will bhe proportion of participants who strictly follow the study protocol (the "per-protocol group") will be estimated with a 95% CI. This includes adherence to treatment (taking the medication correctly for six weeks), study completion (attending all required visits), and providing complete data. To be considered feasible, the lower limit of this 95% CI must be greater than 80%.
Tolerability will be measured by the frequency and nature of adverse events and medication adherence (i.e., missed dosage).
| Arm | Type | Description |
|---|---|---|
| Lemborexant | EXPERIMENTAL | 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). |
| Placebo | PLACEBO_COMPARATOR | Participants will take a 5 mg of placebo pill daily for 2 weeks then 10 mg daily for 4 weeks (total of 6 weeks). |
| Name | Type | Description |
|---|---|---|
| Lemborexant | DRUG | 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. |
| Placebo | OTHER | The placebo is an inactive sugar pill that looks and tastes identical to the lemborexant pill. |
Inclusion Criteria: 1. Aged 18 to 70 (inclusive), with a self-reported body mass index (BMI) between 19 and 30 kg/m2 (inclusive); 2. Meet criteria for primary MDD diagnosis without psychotic symptoms, as defined by the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5)2, an...