ALIPo-D: Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT06111664

Collaborator

(none)

Enrollment

Location

11.8

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mood Disorders

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 24, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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