Melatonin and Response to Lithium
MeLiR
A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.
2 other identifiers
observational
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2023
CompletedFirst Posted
Study publicly available on registry
May 26, 2023
CompletedStudy Start
First participant enrolled
July 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
August 8, 2025
August 1, 2025
2.9 years
May 19, 2023
August 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ratio between 6-sulfatoxy-melatonin (6-SMT) concentration and creatinin concentration on a 12-hours nocturnal urine collection
Ratio between 6-sulfatoxy-melatonin (6-SMT) concentration and creatinin concentration on a 12-hours nocturnal urine collection (8pm to 8am) : * Urine collection will be made on a 12 hours period (20h00-8h00), the night before D30 * at D30 : 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
at day 30
Secondary Outcomes (3)
Level of Proteins
at day 30
Level of mRNA and miRNA
at day 30
Level of plasmatic and intraerythrocytic lithium
at day 30
Study Arms (2)
good-responders (GR) to lithium in euthymic BD-1 individuals
non-responders (NR) to lithium in euthymic BD-1 individuals
Interventions
* 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
* blood sample at V2 (2x3.5mL citrate tubes) * measured by ELISA
* blood sample at V2 (2x2.5mL PAX-gene tube) * measured by quantitative RT-PCR
* blood sample at V2 (mmol/L) * 4mL EDTA tube
Eligibility Criteria
Euthymic BD-1 patients treated by lithium
You may qualify if:
- BD-1 as defined by DSM-5
- Age : 18 to 70
- Current treatment by lithium for more than one year
- Health condition compatible with blood and urinal sampling
- Being affiliated to french social security
- Written consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Fernand-Widal
Paris, Île-de-France Region, 75010, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2023
First Posted
May 26, 2023
Study Start
July 26, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share