Melatonin versus quetiapine in adolescents (MEL-QUE-A)

2024-519597-39-00 Phase II and Phase III (Integrated) Authorised, recruiting

Start 18 Aug 2025 · Status Authorised, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Authorised, recruiting
Participants planned 255
Countries 1
Sites 1

Psychiatric disorder (ICD-10 F20-F69, F84, F90-F95) and insomnia

To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia.

Key facts

Sponsor
Psykiatrisk Center Kobenhavn
Participant type
Pediatric, Patients
Age range
0-17 years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Trial duration
18 Aug 2025 → ongoing
Decision date (initial)
2025-04-14
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Capital Region of Denmark's Research Fund (Region Hovedstadens Forskningsfond, Journalnr. 2024-0101) · Danish Medical Association (Lægeforeningens Forskningsfond, Journalnr. 2023-0037) · Independent Research Fund Denmark (DFF, grant ID: 10.46540/2096-00086B)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia.

Secondary objectives 1

  1. To examine how melatonin or low-dose quetiapine affects global symptom severity, sleep quality, psychosocial functioning, and subjective well-being.

Conditions and MedDRA coding

Psychiatric disorder (ICD-10 F20-F69, F84, F90-F95) and insomnia

Regulatory references

Plan to share IPD
Yes
IPD plan description
After publication of primary and secondary outcomes, data will be handed over to the Danish National Archives (dansk: Rigsarkivet) where data will be archived for 25 years
EU CT numberTitleSponsor
2023-504728-24-00 Efficacy of melatonin, low-dose quetiapine, or placebo in patients with psychiatric disorders and comorbid insomnia: a randomized clinical trial Region Hovedstadens Psykiatriske

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. 16 to 17 years of age
  2. ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-F95)
  3. For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
  4. Self-reported sleep difficulties at least three times per week in the preceding 3 months
  5. Insomnia Severity Index score ≥11
  6. Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect
  7. Women of childbearing potential: negative pregnancy test at baseline and use of highly effective contraception measures
  8. Informed consent provided by both the minor and the legally designated representative

Exclusion criteria 8

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Insomnia severity using the Insomnia Severity Index (ISI)

Secondary endpoints 5

  1. Clinical global impression (CGI)
  2. Subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI)
  3. Psychosocial functioning using the Personal and Social Performance Scale (PSP)
  4. Patient-reported subjective well-being using the WHO-5 well-being index
  5. Rest-sleep-activity cycles and physiological variables

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Quetiapin Sandoz 25 mg filmdrasjerte tabletter

PRD2233998 · Product

Active substance
Quetiapine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
6300 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05AH04 — QUETIAPINE
Marketing authorisation
08-5748
MA holder
SANDOZ A/S
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Encapsulated in lactose-containing gelatin capsules

Melatonin Orifarm 3 mg filmdragerade tabletter

PRD11434328 · Product

Active substance
Melatonin
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL
Max daily dose
9 mg milligram(s)
Max total dose
378 mg milligram(s)
Max treatment duration
6 Week(s)
Authorisation status
Authorised
ATC code
N05CH01 — -
Marketing authorisation
58666
MA holder
ORIFARM GENERICS A/S
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
Encapsulated in lactose-containing gelatin capsules

Placebo 1

Starch and Lactose containing gelatine capsules

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Psykiatrisk Center Kobenhavn

4 Total trials 3 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Psykiatrisk Center Kobenhavn
Address
Esther Ammundsens Vej 36
City
Copenhagen Nv
Postcode
2400
Country
Denmark

Scientific contact point

Organisation
Psykiatrisk Center Kobenhavn
Contact name
Lone Baandrup

Public contact point

Organisation
Psykiatrisk Center Kobenhavn
Contact name
Lone Baandrup

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruiting 255 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Authorised, recruiting
Psykiatrisk Center Kobenhavn
Bispebjerg, Esther Ammundsens Vej 36, 2400, Copenhagen Nv

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-08-18

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2024-519597-39-00 2
Protocol (for publication) D4_Patient facing document_questionnaire_ISI 1
Protocol (for publication) D4_Patient facing document_questionnaire_MEQ-SA-DK 1
Protocol (for publication) D4_Patient facing document_questionnaire_PSQI 1
Protocol (for publication) D4_Patient facing document_questionnaire_Svndagbog 1
Protocol (for publication) D4_Patient facing document_questionnaire_WHO 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements 3
Recruitment arrangements (for publication) K2_ Recruitment material_Pjece A5 2
Recruitment arrangements (for publication) K2_ Recruitment material_Plakat A3 1
Recruitment arrangements (for publication) K2_Recruitment material_Annonce til forskningNU forsoegstjenestenDK og forsoegspersonDK 1
Subject information and informed consent form (for publication) L1_ ICF_Flles samtykkeerklring til forldre og unge 2
Subject information and informed consent form (for publication) L1_ SIS_forldre 3
Subject information and informed consent form (for publication) L1_ SIS_unge 3
Subject information and informed consent form (for publication) L1_ICF_Samtykkeerklring voksne 1
Subject information and informed consent form (for publication) L2_Forldrefuldmagt 1
Subject information and informed consent form (for publication) L2_Other subject information material_Dine rettigheder som forsgsperson 1
Subject information and informed consent form (for publication) L3_Declaration form sole custody 1
Summary of Product Characteristics (SmPC) (for publication) G1_ SmPC Melatonin Orifarm 1
Summary of Product Characteristics (SmPC) (for publication) G1_SmPC Quetiapin Sandoz 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis_DK_2024-519597-39-00 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-01-03 Denmark Acceptable
2025-03-18
 2025-04-14

Related clinical trials