Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT05878730

Melatonin and Response to Lithium

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-08

60

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Melatonin and Response to Lithium

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with bipolar disorder type 1 according to DSM-5
  • Aged 18 to 70 years
  • Currently treated with lithium for more than one year
  • In euthymic state with MADRS score less than 8 and YMRS score less than 8 at inclusion
  • No hospitalization or change in mood-stabilizing treatment in the previous 3 months
  • Health status allows blood and urine sampling
  • Affiliated with French social security
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Use of melatonin, agomelatin, benzodiazepines, or hypnotics in the last 15 days
  • Use of strong CYP1A2 inducers (ciprofloxacine, dihydralazine, fluvoxamine, norfloxacine) in the last month
  • Current substance use disorder except tobacco
  • Chronic renal failure with glomerular filtration rate below 60 mL/min
  • Recent jetlag or life events affecting circadian rhythm (e.g., birth, grief, night work)
  • Sleep disorders such as obstructive sleep apnea, restless leg syndrome, or narcolepsy
  • Pregnancy or breastfeeding
  • Under guardianship
  • Inability to understand French or illiteracy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hôpital Fernand-Widal

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

Actively Recruiting

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Research Team

V

Vincent Hennion, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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