A Phase 2 interventional study of Melatonin and Placebo in Bipolar Affective Disorder, sponsored by Lars Vedel Kessing. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Lars Vedel Kessing · Phase 2, Interventional, and Treatment
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
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 200 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Lars Vedel Kessing is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded.
Drug: Melatonin
100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded.
Drug: Placebo
Oral: Melatonin capsule 6 mg, 1 capsule/day
Oral Placebo capsule, 1 capsule/day
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 months
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 months
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 months
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 months
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 months
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 months
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 months
Non-response to standard mood stabilizing treatment
Non-response to standard mood stabilizing treatment, where standard treatment is defined as lithium or lamotrigine. If one of the following situations occurs after treatment allocation, the date is registrered as "non-response to treatment" defined as: 1. Add-on of a second mood stabilizer (lithium or lamotrigine) in addition to the initial mood stabilizer (lithium or lamotrigine) 2. Add-on of an antidepressant 3. Add-on of quetiapine \> 100 mg/day or another antipsychotic drug The patient will continue the trial follow-up in case of non-response
Time frame: 6 months
Chronotype
Assessed using the Morningness-Eveningness questionnaire (MEQ). (Min. value 16, max. value 86. A value of 41 or below indicate an "evening type". Value of 59 or above indicate a "morning type". Values between 42-58 indicate an "intermediate type")
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Jun 2028, 25 months after the start.
Of 42 non-industry phase 2 interventional studies under Bipolar Disorder, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 63. This study's planned 25 months is below that.
Counting every sponsor, half of 56 studies reached it within 33 months; a quarter within 20 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Melatonin