Familial HypobetalipoproteinemiaNCT03549637
Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)
A study testing Psychiatric population in people with Familial Hypobetalipoproteinemia, run by Nantes University Hospital at 1 site in France.
Trial summary
The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Familial Hypobetalipoproteinemia
- What is being tested?
- Psychiatric population
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 896 participants
- Where
- 1 siteFrance
- Study dates
- 22 Aug 2018to 17 Mar 2021
- Phase
- Interventional
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients hospitalized in one of the full-time adult psychiatric departments of Nantes University Hospital may be included, without maximum age limit.
- Minors and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study
Who cannot join
- minors under 15 years
- pregnant or nursing woman;
- simultaneous participation in another interventional research on a drug;
- not mastering the reading and writing of the French language well enough
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN
The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population.
Read the detailed description
Some forms of hypobetalipoproteinemia (HBL) are associated with a longevity syndrome and cardiovascular protection due to prolonged exposure to low levels of LDL-C. However, while LDL-C reduction has been studied extensively for its beneficial effect on cardiovascular risk, other studies have reported that low levels of LDL-C (either spontaneous or artificially occurring with low-fat diets or lipid-lowering drugs) may be associated with psychiatric symptoms (psychotic or mood disorders, aggression, suicidal attempts, etc.) or altered cognitive performance (particularly executive functioning). These studies have led to contradictory results, and the possible link between low LDL-C levels and psychiatric symptoms remains highly controversial so far.
The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population. Moreover, the study includes the characterization of psychiatric disorders as well as psychological and personal characteristics associated with HBL. The evolutionary profile of patients with and without HBL will be studied. Genetic characteristics and biomarkers of HBL will also be studied.
- Conditions
- Familial Hypobetalipoproteinemia
- Being tested
- Psychiatric population
- Keywords
- Psychiatry, hypobetalipoproteinemia, LDL-Cholesterol
- Medical subject headings
- Hypobetalipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric populationDiagnostic test
Genetic and biological analysis of patients
| Study group | Role | What they receive |
|---|---|---|
| Psychiatric population | Experimental | At inclusion: Patients will have A Lipid Panel Test, other biological analyzes and a clinical assessment. In case of a low LDL-C level (≤ 0, 50 g/L), genetic analyzes will be performed to screen for genetic forms of hypobetalipoproteinemia (HBL).
At 2- 4 weeks: for patients with HBL (LDL-C ≤ 0,50 g/L with no secondary cause of LDL-C reduction), another Lipid Panel Test will be performed to confirm the maintenance of the low LDL-C level.
At 6 months : Patients with a HBL will perform a full biological examination, and the LDL-C levels and genetic analyzes will be confirmed. A dietary survey will be performed, together with a psychiatric assessment. The same numbers of matched controls will performed a quick telephone interview to collect the psychiatric characteristics. Receives: Diagnostic Test: Psychiatric population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C
LDL-C level < 0,50 g/L
Measured: at baseline (admission at the hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start22 Aug 2018
- Primary completion17 Mar 2021
- Study completion17 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial HypobetalipoproteinemiaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie GRALL-BRONNEC, Pr, Principal investigator, Nantes University Hospital Nantes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549637
- Sponsor's protocol ID
- RC17_0468
- Status last verified
- Sep 2021
- First submitted
- 25 May 2018
- Last updated
- 16 Sep 2021
- 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 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN
- ClinicalTrials.gov ID
- NCT03549637
- Acronym / sponsor ID
- RC17_0468
- Conditions
- Familial Hypobetalipoproteinemia
- Keywords
- Psychiatry, hypobetalipoproteinemia, LDL-Cholesterol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 17 Mar 2021 (actual)
- First posted
- 8 Jun 2018 (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.
The links between low LDL-C levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population.
Detailed description
Some forms of hypobetalipoproteinemia (HBL) are associated with a longevity syndrome and cardiovascular protection due to prolonged exposure to low levels of LDL-C. However, while LDL-C reduction has been studied extensively for its beneficial effect on cardiovascular risk, other studies have reported that low levels of LDL-C (either spontaneous or artificially occurring with low-fat diets or lipid-lowering drugs) may be associated with psychiatric symptoms (psychotic or mood disorders, aggression, suicidal attempts, etc.) or altered cognitive performance (particularly executive functioning). These studies have led to contradictory results, and the possible link between low LDL-C levels and psychiatric symptoms remains highly controversial so far.
The PARTITION study aims at estimating the prevalence of hypobetalipoproteinemia (HBL), defined as a LDL-C level ≤ 0,50 g/L, in a psychiatric population. Moreover, the study includes the characterization of psychiatric disorders as well as psychological and personal characteristics associated with HBL. The evolutionary profile of patients with and without HBL will be studied. Genetic characteristics and biomarkers of HBL will also be studied.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychiatric population | Experimental | Diagnostic Test: Psychiatric populationAt inclusion: Patients will have A Lipid Panel Test, other biological analyzes and a clinical assessment. In case of a low LDL-C level (≤ 0, 50 g/L), genetic analyzes will be performed to screen for genetic forms of hypobetalipoproteinemia (HBL). At 2- 4 weeks: for patients with HBL (LDL-C ≤ 0,50 g/L with no secondary cause of LDL-C reduction), another Lipid Panel Test will be performed to confirm the maintenance of the low LDL-C level. At 6 months : Patients with a HBL will perform a full biological examination, and the LDL-C levels and genetic analyzes will be confirmed. A dietary survey will be performed, together with a psychiatric assessment. The same numbers of matched controls will performed a quick telephone interview to collect the psychiatric characteristics. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients hospitalized in one of the full-time adult psychiatric departments of Nantes University Hospital may be included, without maximum age limit.
- Minors and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study
Key exclusion criteria (4 listed)
- minors under 15 years
- pregnant or nursing woman;
- simultaneous participation in another interventional research on a drug;
- not mastering the reading and writing of the French language well enough
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric populationGenetic and biological analysis of patients | Diagnostic test | Psychiatric population |
Primary outcome
Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C
Time frame: at baseline (admission at the hospital)
LDL-C level < 0,50 g/L
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Marie GRALL-BRONNEC, Pr principal investigator
Nantes University Hospital Nantes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric population in people with Familial Hypobetalipoproteinemia, run by Nantes University Hospital 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 16 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C (time frame: at baseline (admission at the hospital)). 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 16 Sep 2021.