Overview
Sponsor-declared trial summary
Bipolar disorder
To conduct a 6-month RCT comparing effects of melatonin versus placebo on mood stabilisation and other critical patient outcomes in patients with bipolar disorder and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypotheses: Add on melatonin improves mood s…
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- 16 Apr 2026 → ongoing
- Decision date (initial)
- 2026-01-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Prophylaxis
To conduct a 6-month RCT comparing effects of melatonin versus placebo on mood stabilisation and other critical patient outcomes in patients with bipolar disorder and to test whether principal effects are antimanic, antidepressant and/or prophylactic against relapse. Primary hypotheses: Add on melatonin improves mood stabilization compared with add on placebo.
Secondary objectives 1
- Secondary objective: Melatonin decreases depression and (hypo)mania and improves functioning and cognition compared with placebo
Conditions and MedDRA coding
Bipolar disorder
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Bipolar disorder with diagnosis confirmed by SCAN interview
- Age 18-70 years
- Speaks and writes danish or english at a level equal to mothers tongue
- Habile (i.e., able to give informed consent)
Exclusion criteria 3
- Past intolerance to melatonin
- Impaired renal or hepatic function
- Women who are pregnant, breastfeeding or planning pregnancy in near future
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system
Secondary endpoints 1
- Hamilton D6, Pittsburgh Sleep Quality, Young Mania Rating Scale, Functioning Assessment Short Test (FAST), internet-based Cognition Assessment Tool (ICAT) and bloodbased inflammation markers in bloodsamples, hair cortisol and urine oxidative stress markers
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10042697 · Product
- Active substance
- Melatonin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 1080 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- N05CH01 — -
- Marketing authorisation
- 21-14030
- MA holder
- ORION CORPORATION
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0
- Max total dose
- 0
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Esther Ammundsens Vej 36
- City
- Copenhagen Nv
- Postcode
- 2400
- Country
- Denmark
Scientific contact point
- Organisation
- Region Hovedstaden
- Contact name
- Lars Vedel Kessing
Public contact point
- Organisation
- Region Hovedstaden
- Contact name
- PCK
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Region Hovedstaden ORG-100003705
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-04-16 | 2026-05-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ MARS Adherence | 1 |
| Protocol (for publication) | D1_COBRA | 1 |
| Protocol (for publication) | D1_FAST_dansk | 1 |
| Protocol (for publication) | D1_Hamilton Depression 17 | 1 |
| Protocol (for publication) | D1_ICAT_ | 1 |
| Protocol (for publication) | D1_M-BipolarProtocol_2025-523549-92-00 | 4 |
| Protocol (for publication) | D1_MEQ | 1 |
| Protocol (for publication) | D1_Monsenso-screenshots_ | 1 |
| Protocol (for publication) | D1_Perceived_Stress | 1 |
| Protocol (for publication) | D1_Pittsburgh Sleep Quality Index | 1 |
| Protocol (for publication) | D1_UKU s Bivirkningsskala Skala Til Registering af Unskede Virkninger af Psykofarmaka | 1 |
| Protocol (for publication) | D1_WHOQOL | 1 |
| Protocol (for publication) | D1_YMRS | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ informed consent form | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_information leaflet adults_ | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SMPC Orimelan | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-24 | Denmark | Acceptable 2026-01-16
|
2026-01-16 |