Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

Familial Hypobetalipoproteinemia Clinical Trial

Official title:

Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549637
• Other study ID #: RC17_0468
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: March 17, 2021

Study information

• Verified date: September 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 896
• Est. completion date: March 17, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Familial Hypobetalipoproteinemia
• Hypobetalipoproteinemias

Intervention

Diagnostic Test:
• Psychiatric population
Genetic and biological analysis of patients

Locations

Country	Name	City	State
France	Nantes University Hospital Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C	LDL-C level < 0,50 g/L	at baseline (admission at the hospital)