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Melatonin and Response to Lithium
Melatonin and Response to Lithium

NCT05878730

RecruitingN/A

Sponsor: Assistance Publique - Hôpitaux de Paris

Conditions: Bipolar Disorder I

Interventions: urine collection, Level of Proteins, Level of mRNA and miRNA, Level of plasmatic and intraerythrocytic lithium

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (1)
  • Paris, Île-de-France Region, France