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Melatonin and Response to Lithium

NCT05878730 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-08-08

No results posted yet for this study

Summary

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

  • Bipolar Disorder I

Interventions

DIAGNOSTIC_TEST

urine collection

* Urine collection will be made on a 12 hours period (20h00-8h00), the night before V2 * at V2 : 2 mL urinal sample for measure of 6-SMT concentration (ng/mL) and creatinin (mg/mL) * Measure of 6-SMT will be made by a validated radio-immunology assay

DIAGNOSTIC_TEST

Level of Proteins

* blood sample at V2 (2x3.5mL citrate tubes) * measured by ELISA

DIAGNOSTIC_TEST

Level of mRNA and miRNA

* blood sample at V2 (2x2.5mL PAX-gene tube) * measured by quantitative RT-PCR

DIAGNOSTIC_TEST

Level of plasmatic and intraerythrocytic lithium

* blood sample at V2 (mmol/L) * 4mL EDTA tube

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-26
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05878730 on ClinicalTrials.gov