The Antiatherogenic Properties of HDL in Psychiatric Patients With and Without Antipsychotic Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Ziv Hospital
Sponsor:
Information provided by (Responsible Party):
Osamah Hussein, Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01215383
First received: October 4, 2010
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

Background:

Among individuals with schizophrenia, there is an increased prevalence of obesity, dyslipidemia ,diabetes mellitus and related conditions such as cardiovascular disease. People with severe mental illnesses, such as schizophrenia, depression or bipolar disorder, have worse physical health and reduced life expectancy compared to the general population. Number of epidemiological studies of patients with schizophrenia have documented a higher incidence of cardiovascular disease than in the general population, and patients with schizophrenia may be at an elevated risk for cardiovascular disease even in the absence of antipsychotic treatment.

Affinity for the H1 receptor is most closely linked to increased weight gain, although affinity for D2, 5-HT1A, 5-HT2C and a2-receptors may also be involved. Drug affinity for the H1, M3 and 5-HT2C receptors is correlated with an increased risk of diabetes.

High-density lipoprotein cholesterol (HDL-C) concentration in the blood is independently and inversely associated with an increased risk of cardiovascular disease(CVD). However many patients with 'normal' or even 'elevated' plasma HDL experience clinical events. HDL may not always be atheroprotective and in some conditions, it paradoxically enhances the process of atherosclerosis. In addition to its role in reverse cholesterol transport, HDL shows many other protective properties towards atherosclerosis. HDL inhibits the chemotaxis of monocytes , prevents endothelial dysfunction and apoptosis, prohibit slow-density lipoprotein (LDL ) oxidation, and stimulates the proliferation of endothelial cells and smooth muscle cells. These anti-inflammatory, antioxidative, antiaggregatory, anti-coagulant, and pro-fibrinolytic activities are exerted by different components of HDL

Aim of the study:

To investigate the functional properties of HDL in psychiatric patients before and during antipsychotic therapy.

Patients and methods:

The blood will be drawn at baseline before the initiation of antipsychotic drugs and 2 months under the antipsychotic treatment.

Study procedures:

Full lipid profile including triglycerides, LDL-C, Total cholesterol, HDL-cholesterol, apo AI, apoAII and apoB100.

Serum Paraoxanase Activity

LDL oxidation and resistance to oxidation (measured by conjugated diens formation during incubation in the presence of copper).

HDL composition: total and unesterified cholesterol, triglycerides and phospholipids, TBARS content before and after exposure to AAPH as a major indicator of oxidative stress, PON activity using phenylacetate as a substrate, apoA1and PAF.

Serum parameters e.g. Diacyl glycerol acyltransferase activity, free ApoA1 and LCAT activity.

3 [H]-Cholesterol efflux will be measured by incubating J744 macrophages with serum. Radioactivity will measured by β counter in the cell lysate and the medium.

Statistical methods:

One-way AVOVA and Student's t-test for paired samples will be used for comparison of multiple groups and paired samples, respectively. p<0.05 will be considered significant.


Condition
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Antiatherogenic Properties of HDL in Psychiatric Patients With and Without Antipsychotic Therapy

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
psychiatric patients
20 in patients and outpatients with schizophrenia, schizoaffective and bipolar disorder based on psychiatrist diagnostic evaluation using DSM-IV criteria, before and at least two months after antipsychotic therapy will be enrolled.
healthy volunteers

Ten healthy volunteers will be checked as controls:

Employee from the hospital staff with no metabolic disease (Diabetes mellitus, hypertension or dyslipidemia) and non-smokers.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

psychiatric patients before and during antipsychotic therapy

Criteria

Inclusion Criteria:

  • in patients and outpatients with schizophrenia, schizoaffective and bipolar disorder based on psychiatrist diagnostic evaluation using DSM-IV criteria, before and at least two months after antipsychotic therapy will be enrolled.

Exclusion Criteria:

  • Unwillingness to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215383

Locations
Israel
Ziv Medical Center (Government Hospital) Recruiting
Safed, Israel, 13110
Contact: Osamah Hussein, MD    +972 4 6828943    osamah@ziv.health.gov.il   
Principal Investigator: Osamah Hussein, MD         
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Osamah Hussein, Head of Internal Medicine Department A, Ziv Hospital
ClinicalTrials.gov Identifier: NCT01215383     History of Changes
Other Study ID Numbers: 0036-10
Study First Received: October 4, 2010
Last Updated: February 19, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
HDL
psychiatric patients
psychiatric patients before and during antipsychotic therapy

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014