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Study on Melatonin and Quetiapine for Treating Insomnia in Adolescents with Psychiatric Disorders

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on adolescents who have both psychiatric disorders and insomnia. The study will explore the effectiveness of two treatments: melatonin and low-dose quetiapine, compared to a placebo. Melatonin is a hormone that helps regulate sleep, while quetiapine is a medication often used to treat mental health conditions. The purpose of the study is to determine how well these treatments work in improving sleep problems in young people with mental health issues.

Participants in the study will be randomly assigned to receive either melatonin, quetiapine, or a placebo. The treatment will be given in the form of film-coated tablets, which are taken orally. The study will last for a period of six months, during which the effects of the treatments on sleep and overall well-being will be monitored. The study aims to provide insights into which treatment might be more effective in managing insomnia in adolescents with psychiatric conditions.

Throughout the study, various aspects of the participants' sleep and mental health will be assessed. This includes measuring the severity of insomnia using the Insomnia Severity Index, evaluating sleep quality, and assessing psychosocial functioning and subjective well-being. The study will also look at how the treatments affect rest-sleep-activity cycles and other physiological variables. The findings from this study could help improve treatment options for young people dealing with both psychiatric disorders and sleep difficulties.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.

    Both you and your legally designated representative must provide consent.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and current health status.

    A pregnancy test will be required for women of childbearing potential, and effective contraception measures must be used.

  3. Step 3

    Baseline evaluation

    You will complete several questionnaires to assess your sleep difficulties and overall well-being. These include the Insomnia Severity Index (ISI) and other related scales.

    This evaluation helps establish a starting point for measuring changes during the trial.

  4. Step 4

    Randomization

    You will be randomly assigned to one of three groups: melatonin, quetiapine, or placebo. A placebo is a substance with no active medication, used for comparison.

    This process ensures that each participant has an equal chance of receiving any of the treatments.

  5. Step 5

    Treatment phase

    If assigned to the melatonin group, you will take Melatonin Orifarm 3 mg film-coated tablets orally.

    If assigned to the quetiapine group, you will take Quetiapin Sandoz 25 mg film-coated tablets orally.

    If assigned to the placebo group, you will take starch and lactose containing gelatine capsules orally.

    The medication will be taken once daily, and the duration of this phase will be specified by the study team.

  6. Step 6

    Follow-up assessments

    Throughout the trial, you will have regular follow-up assessments to monitor your sleep patterns, overall health, and any side effects.

    These assessments will include repeating the initial questionnaires and possibly additional tests to track your progress.

  7. Step 7

    End of trial

    At the end of the trial, a final assessment will be conducted to evaluate the effectiveness of the treatment you received.

    You will be asked to complete the same questionnaires as at the beginning to compare changes in your sleep and well-being.

Who can join the trial?

8 criteria

  • Age between 16 to 17 years old
  • Have a current or past diagnosis of a mental or behavioral disorder according to the ICD-10 codes F20-F69, F84, F90-F95. ICD-10 is a system used by doctors to classify and code all diagnoses.
  • If diagnosed with F84 or F90, must have previously tried treatment with melatonin
  • Experience sleep difficulties at least three times a week for the past 3 months
  • Have an Insomnia Severity Index score of 11 or higher. The Insomnia Severity Index is a questionnaire used to measure the severity of insomnia.
  • Have tried non-medication treatments like sleep hygiene education or using a weighted blanket, but they did not work well enough
  • If a woman who can have children, must have a negative pregnancy test at the start and use highly effective birth control methods
  • Both the minor and their legally designated representative must provide informed consent to participate

Who cannot join the trial?

2 criteria

  • Having a psychiatric disorder such as schizophrenia, mood disorders, or anxiety disorders. These are mental health conditions that affect your mood, thinking, and behavior.
  • Having insomnia, which means having trouble falling asleep or staying asleep.
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Investigated drugs

  • Melatonin

    is a natural hormone that your body produces to help regulate your sleep-wake cycle. In this trial, melatonin is used to help improve sleep in adolescents who have trouble sleeping due to psychiatric disorders. It is being tested to see if it can help these young people fall asleep more easily and have a better quality of sleep.

  • Quetiapine

    is a medication that is often used to treat mental health conditions like depression and bipolar disorder. In this trial, a low dose of quetiapine is being used to see if it can help adolescents with psychiatric disorders who also have trouble sleeping. The goal is to find out if quetiapine can help them sleep better and feel more rested.

What is already known about the treatment

  • Melatonin

    Melatonin is administered orally, typically in the form of tablets or capsules, and is used to help regulate sleep patterns. It is a well-known substance in medicine, often discussed in medical literature for its role in managing sleep disorders. The main therapeutic indication for melatonin in this trial is to treat insomnia, particularly in adolescents with psychiatric disorders. At the molecular level, melatonin works by mimicking the natural hormone produced by the pineal gland, which helps regulate the sleep-wake cycle. It is classified pharmacologically as a sleep aid or hypnotic.

  • Quetiapine

    Quetiapine is administered orally, usually in tablet form, and is used to manage psychiatric disorders. In medical literature, it is recognized for its effectiveness in treating conditions like schizophrenia and bipolar disorder. In this trial, low-dose quetiapine is being evaluated for its potential to treat insomnia in adolescents with psychiatric disorders. At the molecular level, quetiapine works by affecting neurotransmitters in the brain, particularly serotonin and dopamine, which helps stabilize mood and improve sleep. It is classified as an atypical antipsychotic.

Investigated diseases

Insomnia – Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or waking up too early and not being able to return to sleep. It can lead to daytime fatigue, mood disturbances, and difficulty concentrating. The condition can be acute, lasting for a short period, or chronic, persisting for a month or longer. Insomnia can be caused by stress, irregular sleep schedules, poor sleeping habits, mental health disorders, or other medical conditions. Over time, it can affect overall health and quality of life. The severity and impact of insomnia can vary from person to person.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2024-519597-39-00Estimated enrolment255 patientsSponsorPsykiatrisk Center Kobenhavn

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).