NCT07472075 Melatonin Versus Placebo for Bipolar Disorder
| NCT ID | NCT07472075 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Lars Vedel Kessing |
| Condition | Bipolar Affective Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-05-08 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 200 participants in total. It began in 2026-05-08 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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.
Contact & Investigator
Lars Kessing
PRINCIPAL INVESTIGATOR
University hospital Bispebjerg and Frederiksberg Hospital
Frequently Asked Questions
Who can join the NCT07472075 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Bipolar Affective Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07472075 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07472075 currently recruiting?
Yes, NCT07472075 is actively recruiting participants. Contact the research team at lars.vedel.kessing@regionh.dk for enrollment information.
Where is the NCT07472075 trial being conducted?
This trial is being conducted at Frederiksberg, Denmark.
Who is sponsoring the NCT07472075 clinical trial?
NCT07472075 is sponsored by Lars Vedel Kessing. The principal investigator is Lars Kessing at University hospital Bispebjerg and Frederiksberg Hospital. The trial plans to enroll 200 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.