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Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

Primary Purpose

Familial Hypobetalipoproteinemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychiatric population
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Familial Hypobetalipoproteinemia focused on measuring Psychiatry, hypobetalipoproteinemia, LDL-Cholesterol

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nantes University Hospital Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psychiatric population

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C
LDL-C level < 0,50 g/L

Secondary Outcome Measures

Full Information

First Posted
May 25, 2018
Last Updated
September 15, 2021
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03549637
Brief Title
Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)
Official Title
Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
March 17, 2021 (Actual)
Study Completion Date
March 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Hypobetalipoproteinemia
Keywords
Psychiatry, hypobetalipoproteinemia, LDL-Cholesterol

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
896 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychiatric population
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Psychiatric population
Intervention Description
Genetic and biological analysis of patients
Primary Outcome Measure Information:
Title
Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C
Description
LDL-C level < 0,50 g/L
Time Frame
at baseline (admission at the hospital)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie GRALL-BRONNEC, Pr
Organizational Affiliation
Nantes University Hospital Nantes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes University Hospital Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France

12. IPD Sharing Statement

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Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

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