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Melatonin and Response to Lithium

Recruitingn/aAges 18 Years - 70 YearsAllAssistance Publique - Hôpitaux de Paris
NCT05878730 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 rhythm

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📋 Eligibility rules (as published)
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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What it tests

  • urine collection
  • Level of Proteins
  • Level of mRNA and miRNA
  • Level of plasmatic and intraerythrocytic lithium
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Where

1 site
Hôpital Fernand-Widal
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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