Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

Mood Disorders Clinical Trial

— ALIPo-D  

Official title:

Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111664
• Other study ID #: 8953
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: April 24, 2024

Study information

• Verified date: October 2023
• Source: University Hospital, Strasbourg, France
• Contact: Jack FOUCHER, MD, PhD
• Phone: 33 3 88 11 69 21
• Email: jack.foucher[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 24, 2024
• Est. primary completion date: April 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anhedonia
• Mood Disorders

Locations

Country	Name	City	State
France	CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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+)