Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia

Last updated: April 21, 2025
Sponsor: Lone Baandrup
Overall Status: Active - Recruiting

Phase

2/3

Condition

Insomnia

Tic Disorders

Schizotypal Personality Disorder (Spd)

Treatment

Quetiapine

Placebo

Melatonin

Clinical Study ID

NCT06062953
2023-504728-24-00
  • Ages 16-64
  • All Genders

Study Summary

The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:

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

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

Participants will receive six weeks of treatment with either melatonin, quetiapine or placebo followed by a brief taper off.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 16 to 64 years of age

  • ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69,F84, F90-95)

  • For the diagnoses F84 and F90 a previous period of treatment with melatonin isrequired

  • For the 16-17 years old: Non-pharmacological treatment options including sleephygiene education, weighted blanket or other gravity products have been tested withinsufficient effect

  • Self-reported sleep difficulties at least three times per week in the preceding 3months

  • Insomnia Severity Index score ≥11

  • Women of childbearing potential: negative pregnancy test at baseline and use ofhighly effective contraception measures

  • Informed consent

Exclusion

Exclusion Criteria:

  • Current treatment with melatonin or quetiapine

  • Severe somatic comorbidity

  • BMI ≥ 35 kg/m2

  • Breastfeeding

  • Alcohol and/or substance dependency within the last 3 months

  • Inadequate Danish language skills

  • Not able to make an informed consent

  • Increased cardiac risk as assessed by presence of cardiac risk factors, cardiacsymptoms, or prolonged QT-interval at baseline ECG

Study Design

Total Participants: 255
Treatment Group(s): 3
Primary Treatment: Quetiapine
Phase: 2/3
Study Start date:
September 18, 2023
Estimated Completion Date:
February 28, 2029

Connect with a study center

  • Mental Health Center Copenhagen

    Copenhagen NV, 2400
    Denmark

    Active - Recruiting

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