Health Trials

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

ConditionsPsychiatric DisordersInsomnia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age16-64
SponsorLone Baandrup

About this trial

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

Qualifiers

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 is required

For the 16-17 years old: Non-pharmacological treatment options including sleep hygiene education, weighted blanket or other gravity products have been tested with insufficient effect

Disqualifiers

Current treatment with melatonin or quetiapine

Severe somatic comorbidity

BMI ≥ 35 kg/m2

Breastfeeding

Trial design

Treatments tested in this trial

  • Melatonin
  • Quetiapine
  • Placebo

Treatment groups

255 Participants
are divided into 3 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Mental Health Center CopenhagenRecruiting2400, Copenhagen NVDenmarkDenmark

Sponsors and collaborators

Lone Baandrup

Lead sponsor

University of Copenhagen

Sponsor institution

Danish Center for Sleep Medicine

Collaborator

Region Capital Denmark

Collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

Collaborator

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborator

Source ClinicalTrials.gov