Clinical trial • Psychiatry
Melatonin for Bipolar disorder
Clinical trial of Melatonin for Bipolar disorder.
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Bipolar disorder
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-10-2025
- First CTIS Authorization Date
- 16-01-2026
Trial design
Randomised, placebo (placebo oral tablet). test product: orimelan 3 mg tabletter (melatonin) - product presentation indicates 3 mg tablet; maximum daily dose listed as 6 mg; dosing schedule not specified in available documents.-controlled trial across 1 site in Denmark.
- Randomised
- Yes
- Comparator
- Placebo (PLACEBO oral tablet). Test product: Orimelan 3 mg tabletter (melatonin) - product presentation indicates 3 mg tablet; maximum daily dose listed as 6 mg; dosing schedule not specified in available documents.
- Target Sample Size
- 200
- Trial Duration For Participant
- 182
Eligibility
Recruits 200 Habile (i.e., able to give informed consent). Vulnerable population not selected..
- Pregnancy Exclusion
- Women who are pregnant, breastfeeding or planning pregnancy in near future
- Vulnerable Population
- Habile (i.e., able to give informed consent). Vulnerable population not selected.
Inclusion criteria
- {"criterion_text":"- Bipolar disorder with diagnosis confirmed by SCAN interview\n- Age 18-70 years\n- Speaks and writes danish or english at a level equal to mothers tongue\n- Habile (i.e., able to give informed consent)"}
Exclusion criteria
- {"criterion_text":"- Past intolerance to melatonin\n- Impaired renal or hepatic function\n- Women who are pregnant, breastfeeding or planning pregnancy in near future"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mood stabilization will be measured by a mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system","definition_or_measurement_approach":"Mood instability score reflecting the daily variability in self-monitored mood collected via the Monsenso system"}
Secondary endpoints
- {"endpoint_text":"- 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","definition_or_measurement_approach":"Assessment using Hamilton D6, Pittsburgh Sleep Quality Index, Young Mania Rating Scale (YMRS), FAST, ICAT, and laboratory measures including blood-based inflammation markers, hair cortisol and urine oxidative stress markers"}
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 36
- Consent Approach
- Participants must be able to give informed consent ('Habile (i.e., able to give informed consent)'). Participants must speak and write Danish or English at a level equal to mother tongue. Subject information and informed consent form documents are listed in CTIS (L2 documents). No assent process or vulnerable-subject-specific consent procedures are described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 200
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-01-2026
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 5
- Number Of Sites
- 1
- Number Of Participants
- 200
Sites
- Site Name
- Region Hovedstaden - Esther Ammundsens Vej 36
- Department Name
- Ambulatorie for Affektive Lidelser
- Principal Investigator Name
- Lars Kessing
- Principal Investigator Email
- lars.vedel.kessing@regionh.dk
- Contact Person Name
- Lars Kessing
- Contact Person Email
- lars.vedel.kessing@regionh.dk
Sponsor
Primary sponsor
- Full Name
- Region Hovedstaden
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Orimelan 3 mg tabletter
- Active Substance
- Melatonin
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation number 21-14030)
- Maximum Dose
- 6 mg/day
- Investigational Product Name
- PLACEBO
- Active Substance
- PLACEBO
- Modality
- Other
- Routes Of Administration
- Oral use
- Route
- Oral
- Authorisation Status
- Not applicable (placebo)
- Combination Treatment
- Yes
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