Clinical trial NCT03549637: Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)
Official title: Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Familial Hypobetalipoproteinemia
Keywords: Psychiatry, hypobetalipoproteinemia, LDL-Cholesterol
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 896
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C
timeFrame: at baseline (admission at the hospital)
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital Nantes
Study officials:
affiliation: Nantes University Hospital Nantes
name: Marie GRALL-BRONNEC, Pr
role: PRINCIPAL_INVESTIGATOR
References: