Comparing Melatonin, Low-dose Quetiapine, and Placebo to Treat Insomnia in People With Psychiatric Disorders

What this Trial Is About

Researchers are evaluating the effectiveness of melatonin and low-dose quetiapine compared to a placebo for treating insomnia in patients with psychiatric disorders. This randomized, blinded, placebo-controlled clinical trial aims to study how these treatments impact insomnia severity, overall symptom severity, sleep quality, psychosocial functioning, and subjective well-being. The study is investigator-initiated and designed to determine if melatonin or quetiapine shows superiority over placebo in this patient group. Participants will be randomly assigned to one of three groups receiving either melatonin 3-9 mg, low-dose quetiapine 50-150 mg, or placebo 1-3 capsules taken before bedtime. The treatment period lasts six weeks, followed by a brief tapering off phase. Dosing is flexible within the specified ranges to accommodate individual needs. During the trial, participants will be assessed for insomnia severity, clinical global impression, subjective sleep quality, psychosocial functioning, and patient-reported well-being, all measured at six weeks. The study includes careful monitoring, and participants will provide informed consent prior to starting. The total participation duration includes treatment and follow-up assessments over the six-week period.

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