Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03549637
Collaborator
(none)
896
1
1
30.8
29.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Psychiatric population
N/A

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

Study Type:
Interventional
Actual Enrollment :
896 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN
Actual Study Start Date :
Aug 22, 2018
Actual Primary Completion Date :
Mar 17, 2021
Actual Study Completion Date :
Mar 17, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Psychiatric population

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.

Diagnostic Test: Psychiatric population
Genetic and biological analysis of patients

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nantes University Hospital Nantes Nantes France 44000

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Marie GRALL-BRONNEC, Pr, Nantes University Hospital Nantes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT03549637
Other Study ID Numbers:
  • RC17_0468
First Posted:
Jun 8, 2018
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nantes University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2021