Overview
The objective with this study is to conduct a 6-month RCT comparing effects of add-on melatonin versus add-on placebo on mood stabilisation and other critical patient outcomes in patients with BD and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse
Description
Sleep abnormalities are common in all phases of bipolar disorder (BD) and constitute core symptoms of both depression and mania also during remitted phases and despite treatment.
Melatonin is a key circadian hormone, that expresses a robust circadian rhythm and acts as an important endogenous modulator of the circadian timing system of sleep and may thus improve sleep and stabilize BD per se. Nevertheless, sleep in general and melatonin specifically is critically understudied in BD reflecting a central key knowledge gap within psychiatry. The investigators want in a 6-month randomized placebo-controlled trial (RCT) to compare effects of add on melatonin versus add on placebo on mood stabilisation and other critical patient outcomes in patients with BD.
Eligibility
Inclusion Criteria:
- Bipolar disorder with diagnosis confirmed by SCAN interview
- Age 18 - 70 years
- The participants must be able to read and understand the participant information in their native language and consent (English and Danish)
- Habile (i.e able to give informed consent)
Exclusion Criteria:
- Past intolerance to melatonin (allergic reactions)
- Impaired renal or hepatic function (defined by GFR \<60 ml/min and/or ALAT over allowed reference value)
- Women who are pregnant, breastfeeding or planning pregnancy in near future.
