Efficacy of Chronotherapeutic Combination for Major Depressive Episode With Insomnia

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2029

Conditions
Major Depressive Disorder (MDD) With Insomnia
Interventions
PROCEDURE

AD + SHR + active LT and extended-release melatonin 2mg

Patients will receive an SSRI antidepressant (e.g., Fluoxetine, Sertraline, Paroxetine, Escitalopram) or SNRI (e.g., Venlafaxine, Duloxetine) antidepressant (as clinically appropriate), combined with sleep hygiene education, daily morning LT (10,000 lux for 30 minutes between 7-8 a.m. using the Dayvia Slim Style 3 lamp), and 2 mg of extended-release melatonin taken one hour before bedtime, all for a duration of 8 weeks.

PROCEDURE

AD + SHR + active LT and placebo melatonin

Patients will receive an SSRI or SNRI, sleep hygiene instructions, daily morning bright LT (10,000 lux, 30 cm, 30 min, 7-8 a.m., using Dayvia Slim Style 3 lamps), and placebo melatonin taken one hour before bedtime, all for a duration of 8 weeks.

PROCEDURE

AD + SHR + placebo LT and extended-release melatonin 2mg

Patients will receive an SSRI or SNRI, sleep hygiene instructions, daily placebo light exposure (\<10 lux, 30 cm, 30 min, 7-8 a.m., using Dayvia Slim Style 3 lamps in non-therapeutic mode), and 2 mg of extended-release melatonin taken one hour before bedtime, all for a duration of 8 weeks.

PROCEDURE

AD + SHR + placebo LT and placebo melatonin

Patients will receive an SSRI or SNRI, sleep hygiene instructions, daily placebo light exposure (\<10 lux, 30 cm, 30 min, 7-8 a.m., using Dayvia Slim Style 3 lamps), and oral placebo melatonin taken one hour before bedtime, all for a duration of 8 weeks.

Trial Locations (1)

75018

Hôpital Bichat-Claude Bernard, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER