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SchizophreniaNCT01215383

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

An observational study of Schizophrenia and Schizoaffective Disorder, run by Ziv Hospital at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Background: Among individuals with schizophrenia, there is an increased prevalence of obesity, dyslipidemia ,diabetes mellitus and related conditions such as cardiovascular disease. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Type of treatment
Injection or infusion
How many people
20 participants
Where
1 siteIsrael
Study dates
Nov 2010to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: psychiatric patients before and during antipsychotic therapy

Who may be able to join

  • 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.

Who cannot join

  • Unwillingness to participate in the study.

Trial locations and contacts

1 site in 1 country.

Israel1 site, 1 recruiting
  • Ziv Medical Center (Government Hospital)

    Safed, 13110

    Osamah Hussein, MD, +972 4 6828943, osamah@ziv.health.gov.il

    Osamah Hussein, MD

    Recruiting

Other trials in Israel

About this study

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.

Read more

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.

Keywords
HDL, psychiatric patients, psychiatric patients before and during antipsychotic therapy
Medical subject headings
Schizophrenia, Psychotic Disorders, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01215383
Study groupRoleWhat they receive
psychiatric patients20 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 volunteersTen healthy volunteers will be checked as controls: Employee from the hospital staff with no metabolic disease (Diabetes mellitus, hypertension or dyslipidemia) and non-smokers.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01215383
Sponsor's protocol ID
0036-10
Status last verified
Feb 2013
First submitted
4 Oct 2010
Last updated
20 Feb 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Schizoaffective Disorder, run by Ziv Hospital at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.

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