Melatonin Versus Placebo for Bipolar Disorder
ConditionBipolar Affective Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLars Vedel Kessing
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Melatonin
DrugOral: Melatonin capsule 6 mg, 1 capsule/day
Placebo
DrugOral Placebo capsule, 1 capsule/day
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: MelatoninActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mood stabilization
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.
Time frame
6 monthsSecondary outcomes
1
Sleep
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
Time frame
6 months2
Depression
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 )
Time frame
Changes between baseline, 3 months and 6 monthsOther outcomes
1
Mania/hypomania
The clinical rating of (hypo)mania is assessed using the Young Mania Rating Scale (YMRS) (Min. value = 0; max. value = 60 with higher values reflecting more manic symptoms) \[Clinically rated observer-based difference in scores over the 6 months trial, measured at baseline, 3 months and 6 months\]
Time frame
Changes between baseline, 3 months and 6 months2
Functioning
Functioning is assessed using the Functional Assessment Short Test (FAST) (Min. value = 0, max. value = 72 with higher values reflecting poorer function).
Time frame
Changes between baseline, 3 months and 6 months3
Perceived stress
Assessed using Cohen's Perceived Stress Scale (PSS), a 10-item questionnaire. (Min. value = 0; max. value = 40, with higher values reflecting increased stress level)
Time frame
Changes between baseline, 3- and 6 months4
Cognition
Assessed using the self-administered questionnaire, Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) (Min. value = 0; max. value = 48, the higher the score, the higher the number of subjective complaints)
Time frame
Changes between baseline and 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lars Vedel Kessing
Lead sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor institution
Source ClinicalTrials.gov