CClinicalTrials.gg
RecruitingNCT06111664ALIPo-DUpdated Nov 1, 2023

Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

An observational study in Mood Disorders, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

Lithium (Li+) is prescribed to 1‰ of the French population (\~ 60,000 patients). More than half of patients describe subjective symptoms linked to Li+ (SSL) similar to those of chronic fatigue syndrome: muscle weakness, fatigability, cognitive disorders, emotional blunting. SSL are the 2nd cause of stopping Li+ (28%), just behind kidney problems (30%).

In animals, the administration of lithium (Li+) increases the urinary excretion of phosphate (Pi) by 6, inducing phosphate diabetes (DPi). However, idiopathic forms of DPi explain up to 10-15% of chronic fatigue syndromes and these disappear when supplementing with Pi (± vitamin D).

In humans, the introduction of Li+ leads to a reduction in serum phosphate but we have not found any publication on the possible induction of DPi or on a possible link between DPi and SSL.

However, the dosages necessary to detect a DPi are carried out during the annual follow-up assessment of patients on Li+. All you have to do is calculate the standardized maximum reabsorption rate of Pi (TmPi) to make the diagnosis! Finally, if the patients presenting with DPi turn out to be the same as those who complain of SSL, we can imagine that correcting the first by simple supplementation with Pi (± vitamin D) could provide relief.

Read the detailed description

The aim of the study is to determine the prevalence of hypophosphatemia, DPi and SSL in a population of ambulatory patients controlled on Li+ (> 6 months).

02

Conditions studied

  • Mood Disorders

Keywords

  • Diabetes, Phosphate
  • Anergia-anhedonia
  • Lithium (Li+)
  • Mood Disorders
03

In context

Anhedonia

119 studies on the registry are indexed under Anhedonia; 44 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 18 observational studies indexed under Anhedonia.

Browse Anhedonia studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 968 studies on the registry; 344 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Major subject (≥ 18 years old) balanced on Li+ (> 6 months, regardless of the underlying pathology).

Inclusion criteria

  • Major subject (≥ 18 years old)
  • Man or woman
  • Subject balanced on Li+ (> 6 months, regardless of the underlying pathology).
  • Outpatient monitoring by one of the members of CEDRA (Alsace expert center for resistant depression).
  • Subject not opposing, after information, the reuse of their data for the purposes of this research

Exclusion criteria

Exclusion Criteria:

  • Subject having expressed opposition to participating in the study
  • Subject under judicial protection
  • Subject under guardianship or curatorship
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prevalence of hypophosphatemia, DPi and SSL at the population level.

    The prevalence is determined retrospectively on a population balanced on lithium (Li+) for more than 6 months.

    Time frame: from 6 months after lithium treatment (Li+)

07

Study locations

1 of 1 sites recruiting
  • CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • Jack FOUCHER, MD, PhD · Contact · jack.foucher@chru-strasbourg.fr · 33 3 88 11 69 21
    • Ludovic DORMEGNY-JEANJEAN, MD · Contact · ludovic.jeanjean@chru-strasbourg.fr · 33 3 88 11 69 21
    • Jack FOUCHER, MD, PhD · Principal investigator
    • Ludovic DORMEGNY-JEANJEAN, MD · Sub investigator
    • Olivier MAINBERGER, MD · Sub investigator
    • Clément DE BILLY, MD · Sub investigator
    • Camille MEYER, MD · Sub investigator
    • Gilles Bertschy, MD, PhD · Sub investigator
    • Sébastien Weibel, MD · Sub investigator
    • Fabrice Berna, MD, PhD · Sub investigator
    • Benoit Schorr, MD · Sub investigator
    • Jean-Baptiste Causin, MD · Sub investigator
    • Cristina Rusu, MD · Sub investigator
    • Claudia Bota, MD · Sub investigator
    • Ilia Humbert, MD · Sub investigator
    • Géraldine Pfleger, MD · Sub investigator
    • Mihaela Tomsa, MD · Sub investigator
    • Vlad Danila, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06111664
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Nov 1, 2023
Start date
May 1, 2023
Primary completion
Apr 2024 (estimated)
Completion
Apr 24, 2024 (estimated)
Last update
Nov 1, 2023

Study contacts

Jack FOUCHER, MD, PhD
Contact
jack.foucher@chru-strasbourg.fr
33 3 88 11 69 21

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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