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Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)

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ClinicalTrials.gov Identifier: NCT03549637
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 8, 2018
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE August 22, 2018
Estimated Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2018)
Evaluation of primary hypobetalipoproteinemia prevalence defined by a spontaneously low level of LDL-C [ Time Frame: at baseline (admission at the hospital) ]
LDL-C level < 0,50 g/L
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03549637 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN (PARTITION)
Official Title  ICMJE Prevalence of fAmilial hypobetalipopRoTeinemIa in psychiaTrIc pOpulatioN
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Familial Hypobetalipoproteinemia
Intervention  ICMJE Diagnostic Test: Psychiatric population
Genetic and biological analysis of patients
Study Arms  ICMJE 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.

Intervention: Diagnostic Test: Psychiatric population
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2018)
1822
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 22, 2020
Estimated Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie GRALL-BRONNEC, Pr 02.40.84.76.20 marie.bronnec@chu-nantes.fr
Contact: Gaëlle CHALLET 02.40.84.76.20 gaelle.bouju@chu-nantes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03549637
Other Study ID Numbers  ICMJE RC17_0468
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marie GRALL-BRONNEC, Pr Nantes University Hospital Nantes
PRS Account Nantes University Hospital
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP