Investigating how melatonin levels relate to lithium response in bipolar disorder
A Case-control Study Comparing Melatonin Nocturnal Secretion Between Lithium Responders Versus Non Responders in Type 1 Bipolar Disorder.
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT05878730 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris, Île-de-France Region
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.