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Melatonin In Acute Mania Investigation (MIAMI‐UK). A randomized controlled trial of add‐on melatonin in bipolar disorder

Bipolar Disorders Dec 19, 2020

Quested DJ, GibsonJC, Sharpley AL, et al. - In this randomized, double‐blind, parallel‐group, 3‐week comparison, the effectiveness and safety of add‐on melatonin in hypomania or mania were compared over 3 weeks as a well‐tolerated therapy. Modified release melatonin (n = 21) or placebo (n = 20) was administered to adult bipolar patients aged 18‐65 years. Per outcomes, melatonin is not an effective treatment for emerging hypomania or mania. No significant difference were observed between groups in terms of mean Young Mania Rating Scale (YMRS) score at Day 21 and Quick Inventory of Depression Symptomatology Clinician Version‐16 (QIDS‐C16) scores. On the Altman Self Rating Mania Scale (ASRM), significantly fewer patients on melatonin scored 10 or more. Greater proportion of patients in the melatonin group scored less than or equal to 5 on the self‐report QIDS‐SR16 at end‐point.

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