184
Participants
Start Date
September 30, 2025
Primary Completion Date
May 31, 2028
Study Completion Date
May 31, 2029
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.
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.
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.
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.
Hôpital Bichat-Claude Bernard, Paris
Assistance Publique - Hôpitaux de Paris
OTHER