Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

September 18, 2023

Primary Completion Date

February 28, 2029

Study Completion Date

February 28, 2029

Conditions
Psychiatric DisordersInsomnia
Interventions
DRUG

Melatonin

3-9 mg flexible dosing before bed time

DRUG

Quetiapine

50-150 mg flexible dosing before bed time

DRUG

Placebo

1-3 capsules flexible dosing before bed time

Trial Locations (1)

2400

RECRUITING

Mental Health Center Copenhagen, Copenhagen NV

All Listed Sponsors
collaborator

Danish Center for Sleep Medicine

OTHER

collaborator

Region Capital Denmark

OTHER

collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

lead

Lone Baandrup

OTHER

NCT06062953 - Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia | Biotech Hunter | Biotech Hunter