Bipolar Affective Disorder
Conditions
Keywords
Melatonin, Bipolar disorder, Mental disorders, Bipolar and related disorders, Mood disorder
Brief summary
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
Detailed 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.
Interventions
DRUGMelatonin
Oral: Melatonin capsule 6 mg, 1 capsule/day
DRUGPlacebo
Oral Placebo capsule, 1 capsule/day
Sponsors
Lars Vedel Kessing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Double-blinded randomized placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mood stabilization | 6 months | Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system. Patients score their daily mood on a 9-point scale (-3 to +3); scores between -0.5 to 0.5 reflect normal variations, whereas scores of +1, +2 or +3 correspond to mildly, moderately, and severely increased mood and scores of -1, -2 or -3 correspond to mildly, moderately, and severely decreased mood. According to our established methodology, for each participant, we will estimate a mood instability score. Estimates of instability will be based on reading obtained via the Monsenso system which will prompt patients to complete daily mood ratings. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep | 6 months | Change in sleep measured by change from baseline on the Pittsburgh Sleep Quality Index (min. value = 0; max. value = 21 with higher scores indicating poorer sleep quality) on 3 months visit and 6 months visit |
| Depression | Changes between baseline, 3 months and 6 months | The clinical rating of depression is assessed using the Hamilton Rating Scale for Depression, 6 items (HAM-D6), (min. value=0; max. value = 22 with higher scores reflecting more severe depression ) |
Countries
Denmark
Contacts
CONTACTLars Kessing
PRINCIPAL_INVESTIGATORLars Kessing
University hospital Bispebjerg and Frederiksberg Hospital
Outcome results
None listed