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Study on Melatonin and Low-Dose Quetiapine for Patients with Psychiatric Disorders and Insomnia

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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 studying the effectiveness of treatments for patients who have psychiatric disorders along with insomnia, which is a condition where people have trouble sleeping. The trial will test the use of melatonin, a hormone that helps regulate sleep, and quetiapine, a medication often used to treat mental health conditions, against a placebo. The purpose of the study is to see how well these treatments work when added to the usual care that patients are already receiving.

Participants in the study will be randomly assigned to receive either melatonin, low-dose quetiapine, or a placebo. The study will last for a period of six months, during which participants will take the assigned treatment orally in the form of film-coated tablets. Throughout the study, participants will be monitored to assess the severity of their insomnia and their overall well-being.

The trial aims to provide insights into how these treatments can help improve sleep quality and daily functioning in individuals with psychiatric disorders and insomnia. By comparing the effects of melatonin and quetiapine to a placebo, researchers hope to determine the most effective approach to managing these conditions together.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, eligibility is confirmed based on specific criteria such as age between 18 to 64 years, a diagnosis of a psychiatric disorder, and reported sleep difficulties.

    A negative pregnancy test is required for women of childbearing potential, along with the use of effective contraception.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of insomnia using the Insomnia Severity Index (ISI).

    Additional assessments include the Clinical Global Impression (CGI), Pittsburgh Sleep Quality Index (PSQI), Personal and Social Performance Scale (PSP), and the WHO-5 well-being index.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either melatonin, low-dose quetiapine, or a placebo.

    Melatonin is administered as a 3 mg film-coated tablet taken orally.

    Quetiapine is administered as a 25 mg film-coated tablet taken orally.

    The duration and frequency of medication administration are determined by the trial protocol.

  4. Step 4

    Ongoing monitoring

    Participants are monitored regularly to assess the effectiveness of the treatment and any side effects.

    Regular follow-up assessments are conducted using the same scales as the initial assessment to track changes in insomnia severity and overall well-being.

  5. Step 5

    Completion of trial

    Upon completion of the trial, a final assessment is conducted to evaluate the outcomes of the treatment.

    Participants may be provided with information about the results of the trial and any further steps if necessary.

Who can join the trial?

7 criteria

  • Age between 18 and 64 years.
  • 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 been treated 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. This is a questionnaire used to measure the severity of insomnia.
  • Women who can become pregnant must have a negative pregnancy test at the start and use highly effective birth control methods.
  • Must provide informed consent, meaning you agree to participate after understanding the study details.

Who cannot join the trial?

2 criteria

  • Patients with a **psychiatric disorder** such as schizophrenia, mood disorders, or autism spectrum disorders cannot participate.
  • Patients with **insomnia**, which means having trouble sleeping, are excluded.
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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 being used to see if it can help improve sleep in people who have psychiatric disorders and trouble sleeping, known as insomnia. The idea is that by taking melatonin, it might help you 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 tested to see if it can help people with psychiatric disorders who also have insomnia. The goal is to find out if quetiapine can help improve sleep while also supporting mental health treatment.

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 naturally occurring hormone that plays a role in managing the sleep-wake cycle. In medical literature, melatonin is recognized for its potential benefits in treating insomnia, especially in individuals with psychiatric disorders. It works by signaling to the brain that it is time to sleep, thus helping to improve sleep quality and duration. Melatonin is classified as a sleep aid and is often used as a supplement to support regular sleep patterns.

  • Quetiapine

    Quetiapine is usually taken orally in tablet form and is used to treat psychiatric disorders such as schizophrenia and bipolar disorder. In this trial, a low dose of quetiapine is being evaluated for its effectiveness in treating insomnia in patients with psychiatric conditions. Quetiapine works by affecting neurotransmitters in the brain, particularly serotonin and dopamine, which can help stabilize mood and improve sleep. It is classified as an atypical antipsychotic medication and is often used to manage symptoms of mental health disorders.

Investigated diseases

  • Schizophrenia

    Schizophrenia is a chronic psychiatric disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. It often manifests with symptoms such as hallucinations, delusions, disorganized thinking, and impaired functioning. The progression of schizophrenia can vary, with some individuals experiencing episodes of acute symptoms followed by periods of remission. Over time, cognitive and functional impairments may become more pronounced. The disorder typically emerges in late adolescence or early adulthood and can persist throughout a person's life. Social withdrawal and difficulty maintaining employment or relationships are common as the condition progresses.

  • 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, irritability, and difficulty concentrating. Insomnia can be acute, lasting a few days to weeks, or chronic, persisting for a month or longer. Chronic insomnia often results from stress, life events, or habits that disrupt sleep. Over time, it can affect overall health and quality of life. The disorder can occur independently or as a symptom of another medical or psychiatric condition.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-504728-24-00Estimated enrolment255 patientsSponsorPsykiatrisk Center Kobenhavn

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