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Study identifier: NCT06062953 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Psychiatric Disorders · Insomnia  ·  Sponsor: Lone Baandrup

PhasePhase 2/Phase 3
Planned participants255
Who can joinAll sexes, 16 Years to 64 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Lone Baandrup, MD  ·  +4591165903  ·  lone.baandrup@regionh.dk

Always discuss trial participation with your own doctor first.

Locations (1)

Mental Health Center CopenhagenCopenhagen NV, DenmarkRecruiting

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Source record: clinicaltrials.gov/study/NCT06062953