Anergia-anhedonia by Lithium-induced Phosphorus Diabetes (ALIPo-D)

October 26, 2023 updated by: University Hospital, Strasbourg, France

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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France
        • Contact:
        • Sub-Investigator:
          • Olivier MAINBERGER, MD
        • Sub-Investigator:
          • Fabrice BERNA, MD, PhD
        • Sub-Investigator:
          • Sébastien Weibel, MD
        • Sub-Investigator:
          • Gilles Bertschy, MD, PhD
        • Contact:
        • Principal Investigator:
          • Jack FOUCHER, MD, PhD
        • Sub-Investigator:
          • Ludovic DORMEGNY-JEANJEAN, MD
        • Sub-Investigator:
          • Clément DE BILLY, MD
        • Sub-Investigator:
          • Camille MEYER, MD
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of hypophosphatemia, DPi and SSL at the population level.
Time Frame: from 6 months after lithium treatment (Li+)
The prevalence is determined retrospectively on a population balanced on lithium (Li+) for more than 6 months.
from 6 months after lithium treatment (Li+)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 24, 2024

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8953

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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