Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial

Phase 1

Recruiting

Conditions: Psychiatric disorder (ICD-10 F20-F69, F84, F90-F95) and insomnia
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: CTIS2023-504728-24-00

Lead Sponsor: Region Hovedstadens Psykiatriske

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 255

Inclusion Criteria

18 to 64 years of age, ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95), For the diagnoses F84 and F90 a previous period of treatment with melatonin is required, Self-reported sleep difficulties at least three times per week in the preceding 3 months, Insomnia Severity Index score =11, Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures, Informed consent

Exclusion Criteria

Current treatment with melatonin or quetiapine, Severe somatic comorbidity, BMI = 35 kg/m2, Breastfeeding, Alcohol and/or substance dependency (F1X.2) within the last 3 months, Inadequate Danish language skills, Not able to make an informed consent, Increased cardiac risk as assessed by presence of cardiac risk factors, cardiac symptoms, or prolonged QT-interval at baseline ECG

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the trial is to examine the efficacy of melatonin versus low-dose quetiapine versus placebo as augmentation to treatment as usual in patients with psychiatric disorders and comorbid chronic insomnia.;Secondary Objective: To examine how melatonin or low-dose quetiapine affects global symptom severity, To examine how melatonin or low-dose quetiapine affects sleep quality, To examine how melatonin or low-dose quetiapine affects psychosocial functioning, To examine how melatonin or low-dose quetiapine affects subjective well-being;Primary end point(s): Insomnia severity using the Insomnia Severity Index (ISI)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Clinical global impression (CGI);Secondary end point(s):Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI);Secondary end point(s):Psychosocial functioning using the Personal and Social Performance Scale (PSP);Secondary end point(s):Patient-reported subjective well-being using the WHO-5 well-being index