NCT06111664

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 26, 2023

Last Update Submit

October 26, 2023

Conditions

Keywords

Diabetes, PhosphateAnergia-anhedoniaLithium (Li+)Mood Disorders

Outcome Measures

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.

    from 6 months after lithium treatment (Li+)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Mood DisordersHypophosphatemia, Familial

Condition Hierarchy (Ancestors)

Mental DisordersRenal Tubular Transport, Inborn ErrorsKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesHypophosphatemiaPhosphorus Metabolism Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

May 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 24, 2024

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations