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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03549637
Other study ID # RC17_0468
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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)
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05569928 - In Vivo Metabolism of apoB-containing Lipoproteins in ANGPTL3 Deficient Subjects N/A