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A nighttime hormone may hold the key to predicting Lithium's success

NCT ID NCT05878730

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This study investigates whether the amount of melatonin produced at night differs between people with bipolar I disorder who respond well to lithium and those who do not. Researchers will collect urine and blood samples from 60 participants to measure melatonin and other biological markers. The goal is to find a way to predict lithium's effectiveness early, avoiding years of ineffective treatment and its side effects.

What this could mean

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

Active substance
No drug or treatment is being tested. The study compares melatonin secretion between lithium responders and non-responders using urine and blood samples.
What this could lead to
If a link is found, it could lead to a simple urine test that predicts whether lithium will work for a person with bipolar disorder, saving years of ineffective treatment.
What could go wrong
This is a small observational study, so any findings will be preliminary. The link between melatonin and lithium response may not be strong enough to be a reliable predictor.

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.

Participants

About 60 people

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

Started

Jul 2023

Expected to finish

Dec 2026

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.

Who is studied

Euthymic BD-1 patients treated by lithium

Ages

18 to 70 years

Sex

Anyone

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: * BD-1 as defined by DSM-5 * Age : 18 to 70 * Current treatment by lithium for more than one year * Euthymia defined by : MADRS \<8 and YMRS \<8 at inclusion ; no hospitalization or change in mood-stabilizing treatment in the previous 3 months * Health condition compatible with blood and urinal sampling * Being affiliated to french social security * Written consent Exclusion Criteria: * Treatment by : melatonin, agomelatin, benzodiazepines or hypnotic in the last 15 days * Treatment by a strong CYP1A2 inducer in the last month : ciprofloxacine, dihydralazine, fluvoxamine, norfloxacine * Current substance use disorder except for tobacco * Chronic renal failure with glomerular filtration rate \<60mL/min * Jetlag in the last 15 days or life-event impacting circadian rhythmicity (birth, grief, night-work...) * Sleep disorders such as Obstructive Sleep-Apnea, restless leg syndrome, narcolepsy * Pregnancy, breastfeeding * Guardianship * Inability to understand french, illiteracy

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Conditions

The condition(s) this trial relates to.

bipolar I disorder

As listed by the trial registrant

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

Bipolar disorder I

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

  • Hôpital Fernand-Widal

    RECRUITING

    Paris, Île-de-France Region, 75010, France

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