Bipolar Affective DisorderPhase 2M-bipolar RCTNCT07472075
Melatonin Versus Placebo for Bipolar Disorder
A Phase 2 study testing Melatonin in people with Bipolar Affective Disorder, run by Lars Vedel Kessing at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Affective Disorder
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 8 May 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)
Frederiksberg, 2000
Lars Vedel Kessing, +45 38647081, lars.vedel.kessing@regionh.dk
About this study
Official title: Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled 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
Read the 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.
- Conditions
- Bipolar Affective Disorder
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, Bipolar disorder, Mental disorders, Bipolar and related disorders, Mood disorder
- Medical subject headings
- Bipolar Disorder, Mental Disorders, Bipolar and Related Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Oral: Melatonin capsule 6 mg, 1 capsule/day
PlaceboDrug
Oral Placebo capsule, 1 capsule/day
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | 100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded. Receives: Drug: Melatonin |
| Placebo | Placebo comparator | 100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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
Measured: 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 )
Measured: Changes between baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start8 May 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Affective DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lars Vedel Kessing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lars Vedel Kessing, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Lars Kessing, Principal investigator, University hospital Bispebjerg and Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472075
- Sponsor's protocol ID
- EUCT2025-523549-92-00
- Other IDs
- Grant ID: 10.46540/00004B
- Acronym
- M-bipolar RCT
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Versus Placebo for Bipolar Disorder - a Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07472075
- Acronym / sponsor ID
- M-bipolar RCT / EUCT2025-523549-92-00
- Conditions
- Bipolar Affective Disorder
- Keywords
- Melatonin, Bipolar disorder, Mental disorders, Bipolar and related disorders, Mood disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lars Vedel KessingUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: Melatonin100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded. |
| Placebo | Placebo comparator | Drug: Placebo100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninOral: Melatonin capsule 6 mg, 1 capsule/day | Drug | Melatonin |
| PlaceboOral Placebo capsule, 1 capsule/day | Drug | Placebo |
Primary outcome
Mood stabilization
Time frame: 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.
2 secondary outcomes
Sleep
Time frame: 6 months
Depression
Time frame: Changes between baseline, 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Kessing principal investigator
University hospital Bispebjerg and Frederiksberg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Bipolar Affective Disorder, run by Lars Vedel Kessing at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lars Kessing (+45 38647081, lars.vedel.kessing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood stabilization (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.