Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial

What this Trial Is About

Researchers are studying bipolar disorder, focusing on how adding melatonin compares to a placebo in helping stabilize mood and improve important patient outcomes. This randomized controlled trial aims to evaluate whether melatonin has antimanic, antidepressant, or relapse-preventing effects over six months. Sleep problems are common in bipolar disorder and affect mood phases, so this study explores melatonin's potential role as a key hormone regulating sleep and circadian rhythms. The study involves two groups of patients with bipolar disorder. One group will receive 6 mg of melatonin each evening, while the other group will receive a placebo capsule. Both patients and researchers will be unaware of which treatment each participant receives, ensuring a double-blind setup. The trial will last for six months, during which the effects on mood stabilization and other outcomes will be examined. Participants will undergo assessments throughout the six months to track mood stabilization, sleep quality, and changes in depression symptoms. Researchers will use interviews and clinical evaluations to measure these outcomes at baseline, three months, and six months. The study includes safety monitoring and informed consent, with all care and medication provided as part of the trial process.

Melatonin Versus Placebo for Bipolar Disorder