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.
Plain-language title generated from the registry record
Registry title: Melatonin and Response to Lithium
Key facts
- Where
- Paris, FranceSee the site
Could this be for you?
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?
Source: NCT05878730, who can take part
Where in France
- Hopital Fernand WidalParis, FranceTaking people
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?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05878730
- Record updated
- 18 August 2026
- Original description
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
A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.
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.
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.
Inclusion: 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: 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.