A Phase 3 interventional study of Pediatric Prolonged-Released Melatonin (PedPRM) and Placebo in Anorexia Nervosa and Sleep Disorders in Children, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 1 site in France. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 3, Interventional, and Treatment
Sleep disturbances are reported by more than 50% of patients with Anorexia Nervosa (AN) and are associated with increased AN severity, psychiatric comorbidities, and poorer quality of life. To date, no pharmacological treatment has been approved or recommended for sleep disorders in children and adolescents with AN. Many drugs are currently prescribed off-label for their sedative side effects, without proven safety or efficacy in this population.
Pediatric prolonged-release melatonin (PedPRM, Slenyto®) is the only melatonin formulation approved by the European Medicines Agency (EMA) for chronic insomnia in children aged 2 to 18 years with neurodevelopmental disorders. Its excellent safety profile, absence of tolerance, and long-acting formulation make it a prime candidate for treating sleep disturbances in children and adolescents with AN.
MELSom-ANOREXIA is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase IIIb trial. Its primary objective is to assess the efficacy of PedPRM compared to placebo in improving Total Sleep Time (TST) in children and adolescents aged 6 to 18 years with AN and impaired sleep.
Participants are randomized into two groups: the experimental group receives PedPRM (2 mg or 5 mg depending on response at Day 22) and the control group receives a matching placebo, both administered 0.5 to 1 hour before habitual bedtime for 13 weeks. Sleep is assessed by Sleep Diary and actigraphy. Secondary outcomes include other sleep parameters, AN severity (BMI, EDI-2, EDE-Q), associated symptoms (anxiety, depression, physical activity, executive function, emotionality), and quality of life. Melatonin secretion profiles and specific subgroups (ASD traits, early-onset AN) are also explored.
The study includes a 2-week run-in period (D-14 to D0) for baseline sleep assessment, followed by 13 weeks of treatment, with visits at D0, D22, and D93. A total of 120 participants will be enrolled across 7 French pediatric psychiatry centers over 24 months.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Participants aged 6 to 18 years, inclusive, with a diagnosis of Anorexia Nervosa (AN) according to criteria Presence of a sleep problem for at least 1 month, defined as ≤ 6 hours of continuous sleep and/or ≥ 0.5 hours sleep latency from lights-off on 3 out of 5 nights, based on participant report (with or without parental assistance according to age), confirmed at D0 by 2-week sleep diary No response to at least 4 weeks of sleep hygiene Negative pregnancy test at baseline, prior to randomization, for female participants of Women of childbearing potential must agree to use a highly effective method of during the study treatment period and for at least 4 weeks after the last dose of study treatment Written obtained in accordance with the participant's legal status and applicable regulations Affiliation to a social security system or equivalent
EXCLUSION CRITERIA
Known diagnosis of another significant sleep disorder (e.g. moderate to severe sleep apnea) Use of prohibited medication (z-drugs, melatonin agonist, benzodiazepine, phenylpiperazine class, clomethiazole) or melatonin within 2 weeks prior to screening Declared allergy to melatonin, lactose, or any included in the therapeutic units Pregnant or breastfeeding female participants Unresponsiveness to previous prolonged-release melatonin within the 2 years prior to the study Start of cognitive behavioural therapy (CBT) targeting sleep disturbances or mood disorders within 6 weeks before study inclusion Trans-meridian travel (> 2 time zones) within the month before the start of the study Patient under legal protection regimen
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive pediatric prolonged-release melatonin (PedPRM, Slenyto®) orally, 0.5 to 1 hour before habitual bedtime, every evening for 13 weeks. Starting dose is 2 mg (2 × 1 mg tablets). At Day 22, dose is increased to 5 mg (1 × 5 mg tablet) in case of insufficient sleep improvement (less than 1 hour improvement in sleep latency and/or total sleep time from baseline).
Drug: Pediatric Prolonged-Released Melatonin (PedPRM)
Participants receive a matching placebo orally, 0.5 to 1 hour before habitual bedtime, every evening for 13 weeks. At Day 22, placebo units are adjusted in the same manner as the experimental group to maintain blinding.
Drug: Placebo
Pediatric prolonged-release melatonin mini-tablets (Slenyto® 1 mg and 5 mg, Neurim Pharmaceuticals). Oral administration 0.5 to 1 hour before habitual bedtime every evening for 13 weeks. Initial dose: 2 mg/day (2 × 1 mg tablets). Dose may be increased to 5 mg/day (1 × 5 mg tablet) at Day 22 in case of insufficient sleep improvement.
Matching placebo mini-tablets, identical in appearance and formulation to the PedPRM therapeutic units. Oral administration 0.5 to 1 hour before habitual bedtime every evening for 13 weeks. Number of units adjusted at Day 22 to match the experimental group and maintain blinding.
Change from baseline in mean Total Sleep Time (TST) measured by Sleep Diary
Time frame: Baseline (Day-14 to Day 0) and end of treatment (Day 78 to Day 93)
Change from baseline in mean Sleep Latency (SL) measured by Sleep Diary
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean Wake After Sleep Onset (WASO) measured by Sleep Diary
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean number of awakenings measured by Sleep Diary
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in mean Longest Sleep Episode (LSE) measured by Sleep Diary
Time frame: Baseline and end of treatment (D78 to D93)
Change from baseline in mean Total Sleep Time
Time frame: Baseline and end of treatment (Day 78 to Day 93)
Change from baseline in Body Mass Index (BMI)
Time frame: Baseline (Day 0), Day 22 and end of treatment (Day 93)
Change from baseline in Eating Disorder Inventory-2 (EDI-2) total score
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in Eating Disorder Examination-Questionnaire (EDE-Q) score
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in executive function (BRIEF-P score)
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in emotionality (EPN-31 score)
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Change from baseline in depressive symptoms (CDI score)
Time frame: Baseline (Day 0) and end of treatment (Day 93)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2029, 28 months later.
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This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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