Bipolar Disorder Trial, Recruiting NCT05878730 Sponsor: Assistance Publique - Hôpitaux de Paris Condition: Bipolar Disorder
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Bipolar Disorder Trial, Recruiting

NCT05878730
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with Bipolar Disorder Type 1 (BD-1) according to standard psychiatric guidelines (DSM-5)
  • People aged between 18 and 70 years old
  • People who have been taking lithium as part of their treatment for more than one year
  • People whose mood is currently stable — meaning low scores on standard mood assessment scales, no hospital stays, and no changes to their mood-stabilising medication in the past 3 months
  • People who are in a general health condition that allows for blood and urine samples to be taken
  • People who are enrolled in the French social security system
  • People who are able to provide written consent to participate

Who may not be able to join:

  • People who have taken melatonin, agomelatine, benzodiazepines, or sleeping tablets in the last 15 days
  • People who have taken certain specific medications (ciprofloxacin, dihydralazine, fluvoxamine, or norfloxacin) in the last month, as these can interfere with how the body processes certain substances
  • People who currently have a substance use disorder (excluding tobacco)
  • People who have chronic kidney disease with significantly reduced kidney function (confirm with trial site)
  • People who have experienced jet lag in the last 15 days, or a major life event that may have disrupted their sleep-wake cycle, such as a birth, bereavement, or night shift work
  • People who have a diagnosed sleep disorder, such as obstructive sleep apnoea, restless legs syndrome, or narcolepsy
  • People who are pregnant or breastfeeding
  • People who are under legal guardianship
  • People who are unable to understand French or who are unable to read or write

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 01 40 05 42 08

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
26 July 2023
Est. completion
1 July 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Ratio between 6-sulfatoxy-melatonin (6-SMT) concentration and creatinin concentration on a 12-hours nocturnal urine collection

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov