Compares melatonin at night in bipolar I patients responding or not to lithium
Compares night melatonin in bipolar I adults who respond or not to lithium.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Melatonin and Response to Lithium
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 26 Jul 2023
- Expected to end
- Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- urine collection
- Level of Proteins
- Level of mRNA and miRNA
- Level of plasmatic and intraerythrocytic lithium
- Record updated
- 18 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 bipolar disorder who have taken lithium for more than one year and are currently in a stable mood.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Type 1 bipolar disorder (BD-1, as defined by DSM-5), in a stable mood (euthymia): MADRS <8 and YMRS <8, with no hospital stay or change in mood-stabilizing treatment in the previous 3 months.
- Earlier treatment
- Must have been treated with lithium for more than one year. Must not have taken melatonin, agomelatin, benzodiazepines or hypnotic medicines in the last 15 days, or a strong CYP1A2 inducer (ciprofloxacine, dihydralazine, fluvoxamine, norfloxacine) in the last month.
Main reasons for not taking part
- Current substance use disorder, except tobacco
- Chronic kidney failure with glomerular filtration rate <60mL/min
- Jetlag in the last 15 days, or a life event affecting body rhythms (birth, grief, night-work)
- Sleep disorders such as obstructive sleep apnea, restless leg syndrome or narcolepsy
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current substance use disorder except for tobacco
- Chronic renal failure with glomerular filtration rate <60mL/min
- Sleep disorders such as Obstructive Sleep-Apnea, restless leg syndrome, narcolepsy
- 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
- Jetlag in the last 15 days or life-event impacting circadian rhythmicity (birth, grief, night-work...)
- Pregnancy, breastfeeding
- Guardianship
- Inability to understand french, illiteracy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Where in France
- Hopital Fernand WidalParis, FranceContact: Vincent Hennion, MDTaking people
About the trial
What the trial wants to find out
Bipolar disorders are mental illnesses characterized by the recurrence of mood-episodes, that can have a severe impact on the life of individuals. The effect of lithium, one of the main medications used to treat acute episodes or prevent them from happening, is very different from one individual to an-other. So far, there is no way to predict in advance for whom patient this treatment will be effective or for whom it will not.
Read full original descriptionShow less
Finding markers that can predict as early as possible the efficiency of this treatment is a major field of current research in psychiatry, in order to avoid maintaining an inefficient treatment for several years that can have negative side-effects.
Over the past decades, it has been shown by multiple studies that lithium can act on the biological clock, that regulates circadian rhythmicity of the body (i.e. rhythms that presents a 24 hours periods, such as rhythms of sleep and activity, feeding, social activities...). But it is still very unclear whether the effect of lithium in regulating the mood in bipolar disorders is mediated by this action.
Melatonin is one of the key-regulator of circadian rhythmicity of the human body. Our hypothesis, based on some previous studies, is that the action of lithium in type-1 bipolar disorder (BD-I) is related to an action on melatonin secretion.
To test that, we want in this study to compare the noctunal secretion of melatonin between BD-I individuals with a good response to lithium versus with a poor response to lithium.
The 2 groups in the trial
- good-responders (GR) to lithium in euthymic BD-1 individuals
Treatment: urine collection, Level of Proteins, Level of mRNA and miRNA, and Level of plasmatic and intraerythrocytic lithium
- non-responders (NR) to lithium in euthymic BD-1 individuals
Treatment: urine collection, Level of Proteins, Level of mRNA and miRNA, and Level of plasmatic and intraerythrocytic lithium
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.
- Plain-language title
- Compares melatonin at night in bipolar I patients responding or not to lithiumGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05878730, who can take part
- Record updated
- 18 August 2026