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Could a sleep hormone tame bipolar mood swings?

NCT ID NCT07472075

Disease control Sponsor: Lars Vedel Kessing Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding melatonin (a natural sleep hormone) to standard treatment can help stabilize daily mood swings in people with bipolar disorder. Two hundred adults with bipolar disorder will take either a melatonin capsule or a placebo every day for six months. Their mood stability will be tracked using a smartphone app.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Melatonin
What this could lead to
If it works, this could point toward a simple, low-cost add-on treatment to help stabilize mood in bipolar disorder.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to everyone. Melatonin may not improve mood stability more than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Bipolar and Related Disorders bipolar disorder major affective disorder 6 mood disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar affective disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Frederiksberg, 2000, Denmark

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