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Clinical Trials/NCT06111664
NCT06111664RecruitingNot Applicable

Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

University Hospital, Strasbourg, France1 site in 1 country60 target enrollmentStarted: May 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Prevalence of hypophosphatemia, DPi and SSL at the population level.

Study Overview

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.

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
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Strasbourg, France
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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