Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

Not Applicable

Completed

• Conditions: Familial Hypobetalipoproteinemia

• Registration Number: NCT03549637
• Lead Sponsor: Nantes University Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Study Start: 2018-08-22
• Primary Completion: 2021-03-17
• Study Completion: 2021-03-17
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-15
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 896

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C	at baseline (admission at the hospital)	LDL-C level \< 0,50 g/L

Trial Locations

Locations (1)

Nantes University Hospital Nantes; 🇫🇷 Nantes, France