NCT07472075

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
24mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Jun 2028

First Submitted

Initial submission to the registry

March 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 8, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

May 12, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

March 1, 2026

Last Update Submit

May 7, 2026

Conditions

Bipolar Affective Disorder

Keywords

MelatoninBipolar disorderMental disordersBipolar and related disordersMood disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (2)

  • Sleep

    6 months

  • Depression

    Changes between baseline, 3 months and 6 months

Other Outcomes (6)

  • Mania/hypomania

    Changes between baseline, 3 months and 6 months

  • Functioning

    Changes between baseline, 3 months and 6 months

  • Perceived stress

    Changes between baseline, 3- and 6 months

  • +3 more other outcomes

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

100 BD patients will receive 6 mg melatonin every evening. Patients, clinicians and researchers will be blinded.

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

100 BD patients will receive placebo. Patients, clinicians and researchers will be blinded.

Drug: Placebo

Interventions

MelatoninDRUG

Oral: Melatonin capsule 6 mg, 1 capsule/day

Melatonin
PlaceboDRUG

Oral Placebo capsule, 1 capsule/day

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Center Copenhagen, Copenhagen Affective Research Center (CADIC)

Frederiksberg, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Bipolar DisorderMental DisordersBipolar and Related DisordersMood Disorders

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Lars Kessing

    University hospital Bispebjerg and Frederiksberg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Kessing

CONTACT

+45 38647081lars.vedel.kessing@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded randomized placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 16, 2026

Study Start

May 8, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

May 12, 2026

Record last verified: 2026-04

Locations

DK(1)