Mood DisordersALIPo-DNCT06111664
Anergia-anhedonia by Lithium-induced Phosphorus Diabetes
An observational study of Mood Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mood Disorders
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 24 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Major subject (≥ 18 years old) balanced on Li+ (> 6 months, regardless of the underlying pathology).
Who may be able to join
- 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
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject under judicial protection
- Subject under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CENTRE DE NEUROMODULATION NON INVASIVE DE STRASBOURG (CEMNIS) - CHU de Strasbourg - France
Strasbourg, 67091
Jack FOUCHER, MD, PhD, 33 3 88 11 69 21, jack.foucher@chru-strasbourg.fr
Ludovic DORMEGNY-JEANJEAN, MD, 33 3 88 11 69 21, ludovic.jeanjean@chru-strasbourg.fr
About this study
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).
Read more
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.
Read the 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).
- Conditions
- Mood Disorders
- Keywords
- Diabetes, Phosphate, Anergia-anhedonia, Lithium (Li+), Mood Disorders
- Medical subject headings
- Mood Disorders, Hypophosphatemia, Familial
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from 6 months after lithium treatment (Li+)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 May 2023
- Primary completionApr 2024 (estimated)
- Study completion24 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111664
- Sponsor's protocol ID
- 8953
- Acronym
- ALIPo-D
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anergia-anhedonia by Lithium-induced Phosphorus Diabetes
- ClinicalTrials.gov ID
- NCT06111664
- Acronym / sponsor ID
- ALIPo-D / 8953
- Conditions
- Mood Disorders
- Keywords
- Diabetes, Phosphate, Anergia-anhedonia, Lithium (Li+), Mood Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 24 Apr 2024 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥ 18 years old) balanced on Li+ (> 6 months, regardless of the underlying pathology).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Subject having expressed opposition to participating in the study
- Subject under judicial protection
- Subject under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jack FOUCHER, MD, PhD (33 3 88 11 69 21, jack.foucher@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypophosphatemia, DPi and SSL at the population level. (time frame: from 6 months after lithium treatment (Li+)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.