Investigating how melatonin levels relate to lithium response in bipolar disorder
Official title: A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.
Run by Assistance Publique - Hôpitaux de Paris · NCT05878730 · Data updated 2026-11-12
This study is trying to see if melatonin levels can help predict how well lithium treatment works for people with Bipolar Disorder I.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | July 26, 2023 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT05878730 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are euthymic adults aged 18 to 70 with Bipolar Disorder I who have been on lithium treatment for more than a year.
✕Probably not a fit
Patients currently using melatonin or other specified medications, those with certain sleep disorders, or individuals who have experienced significant life events affecting circadian rhythms may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to identify biomarkers that can predict the effectiveness of lithium treatment in individuals with Bipolar Disorder I. It compares the urinary nocturnal secretion of melatonin and levels of specific proteins and mRNA between good-responders and non-responders to lithium. Participants will be euthymic patients currently treated with lithium for over a year, and their response will be assessed using validated scales. The study involves urine collection, blood sampling, and completion of various questionnaires to gather comprehensive clinical data.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for patients with bipolar disorder, minimizing ineffective treatments and their side effects.
How similar studies have gone: While the approach of identifying biomarkers for treatment response is being explored in various contexts, this specific study's focus on melatonin and lithium response is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hôpital Fernand-Widal
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Vincent Hennion, MD
- Email: vincent.hennion@aphp.fr
- Phone: 01 40 05 42 08
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using magnetic stimulation to improve cognition in psychotic disorders
This study is testing whether a type of brain stimulation called TMS can help improve thinking skills in people with psychotic disorders like schizophrenia and bipolar disorder.
-
Collection of blood samples to study inflammation in psychiatric disorders
This study is trying to see if blood samples from people with psychiatric disorders like schizoaffective disorder and bipolar disorder can help us understand inflammation and improve diagnosis and treatment.
-
Testing BXCL501 for agitation in children with schizophrenia and bipolar disorder
This study is testing if a new medication called BXCL501 can help reduce agitation in children and teens aged 10-17 with bipolar disorder or schizophrenia.
-
Effects of comorbidity on people with severe mental illness
This study tests how having both alcohol/substance use and a severe mental illness affects hospitalizations, medications, and social participation among adults followed at a mental health center.
-
Venous Tourniquet with Low-Dose Sugammadex vs Arterial Tourniquet for Seizure Monitoring During ECT
40 patients undergoing ECT will have a venous tourniquet on one arm and an arterial tourniquet on the other to see which method better reveals motor seizures.
-
7T MRI and visual perception markers for severe mood and psychotic disorders
This project tests whether 7‑tesla MRI scans combined with visual perception tests can identify brain markers linked to diagnosis and treatment outcomes in adults with major depressive disorder, bipolar disorder, or schizophrenia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.