MELATONIN for Psychiatric disorder | Insomnia

Inclusion criteria

• {"criterion_text":"- 16 to 17 years of age\n- ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95)\n- For the diagnoses F84 and F90 a previous period of treatment with melatonin is required\n- Self-reported sleep difficulties at least three times per week in the preceding 3 months\n- Insomnia Severity Index score ≥11\n- Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect\n- Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures\n- Informed consent provided by both the minor and the legally designated representative"}

Exclusion criteria

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

Primary endpoints

• {"endpoint_text":"- Insomnia severity using the Insomnia Severity Index (ISI)","definition_or_measurement_approach":"Measured using the Insomnia Severity Index (ISI)."}

Secondary endpoints

• {"endpoint_text":"- Clinical global impression (CGI)","definition_or_measurement_approach":"Measured using the Clinical Global Impression (CGI) scale."}
• {"endpoint_text":"- Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI)","definition_or_measurement_approach":"Measured using the Pittsburgh Sleep Quality Index (PSQI)."}
• {"endpoint_text":"- Psychosocial functioning using the Personal and Social Performance Scale (PSP)","definition_or_measurement_approach":"Measured using the Personal and Social Performance Scale (PSP)."}
• {"endpoint_text":"- Patient-reported subjective well-being using the WHO-5 well-being index","definition_or_measurement_approach":"Measured using the WHO-5 well-being index."}
• {"endpoint_text":"- Rest-sleep-activity cycles and physiological variables","definition_or_measurement_approach":"Rest-sleep-activity cycles and physiological variables (measurement approach not specified in CTIS record)."}

Methods

• Plakat A3 (recruitment poster) — indicated by document title 'K2_ Recruitment material_Plakat A3' (channel: poster; target audience: adolescents and parents in Denmark).
• Online advertisement to research volunteer portals — indicated by document title 'K2_Recruitment material_Annonce til forskningNU forsoegstjenestenDK og forsoegspersonDK' (channels: online research volunteer portals; target audience: adolescents/parents in Denmark).
• Leaflet A5 — indicated by document title 'K2_ Recruitment material_Pjece A5' (channel: leaflet/brochure; target audience: adolescents and parents in Denmark).
• Recruitment arrangements document 'K1_ Recruitment arrangements' (procedural recruitment arrangements; country: Denmark).

Denmark

Earliest CTIS Part Ii Submission Date

21-03-2025

Latest Decision Or Authorization Date

14-04-2025

Processing Time Days

24

Number Of Sites

1

Number Of Participants

255

Primary sponsor

Full Name

Psykiatrisk Center Kobenhavn

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}