Efficacy and Safety of Daridorexant in Patients with Major Depressive Disorder (MDD) and Insomnia: Double-blind, randomized, controlled trial

Conditions

Patients with major depressive episode and moderate to severe insomnia disorder

Brief summary

Improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) at 3 months.

Detailed description

To evaluate the efficacy of Daridorexant compared with placebo in improving insomnia as measured by overnight polysomnography at 3 months, including sleep latency, total sleep time, wake after sleep onset., To evaluate the efficacy of Daridorexant compared with placebo in improving depressive symptoms in patients with Major Depressive Disorder (MDD) at 3 months, measured by Montgomery–Åsberg Depression Rating Scale (MADRS), MINI Suicide Module., To evaluate the safety of Daridorexant compared with placebo by monitoring worsening of depressive symptoms, emergence of suicidal ideation at baseline and at 3 months., To compare the side-effect profile of Daridorexant with placebo over the 3-month treatment period., To evaluate the efficacy of Daridorexant compared with placebo in improving quality of life, measured by the EuroQol (EQ-5D) after insomnia treatment at 3 months.

Related papers

No related papers found yet.

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Interventions

DRUGCELLULOSE

DRUGMICROCRYSTALLINE

DRUGCOLLOIDAL SILICON DIOXIDE

DRUGCROSCARMELLOSE SODIUM

DRUGMAGNESIUM STEARATE

DRUGDARIDOREXANT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Improvement in insomnia severity, measured by the Insomnia Severity Index (ISI) at 3 months.	—

Secondary

Measure	Time frame
To evaluate the efficacy of Daridorexant compared with placebo in improving insomnia as measured by overnight polysomnography at 3 months, including sleep latency, total sleep time, wake after sleep onset., To evaluate the efficacy of Daridorexant compared with placebo in improving depressive symptoms in patients with Major Depressive Disorder (MDD) at 3 months, measured by Montgomery–Åsberg Depression Rating Scale (MADRS), MINI Suicide Module., To evaluate the safety of Daridorexant compared with placebo by monitoring worsening of depressive symptoms, emergence of suicidal ideation at baseline and at 3 months., To compare the side-effect profile of Daridorexant with placebo over the 3-month treatment period., To evaluate the efficacy of Daridorexant compared with placebo in improving quality of life, measured by the EuroQol (EQ-5D) after insomnia treatment at 3 months.	—

Measure

Time frame

To evaluate the efficacy of Daridorexant compared with placebo in improving insomnia as measured by overnight polysomnography at 3 months, including sleep latency, total sleep time, wake after sleep onset., To evaluate the efficacy of Daridorexant compared with placebo in improving depressive symptoms in patients with Major Depressive Disorder (MDD) at 3 months, measured by Montgomery–Åsberg Depression Rating Scale (MADRS), MINI Suicide Module., To evaluate the safety of Daridorexant compared with placebo by monitoring worsening of depressive symptoms, emergence of suicidal ideation at baseline and at 3 months., To compare the side-effect profile of Daridorexant with placebo over the 3-month treatment period., To evaluate the efficacy of Daridorexant compared with placebo in improving quality of life, measured by the EuroQol (EQ-5D) after insomnia treatment at 3 months.

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Outcome results

None listed