NCT05878730Recruiting
Melatonin and Response to Lithium
A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 19 May 2023
- Start date
- 26 Jul 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Bipolar disorder
- NCT number
- NCT05878730
What you commit to
- Study type: Observational
- Planned participants: 60
- From 26 Jul 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Fernand Widal Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.