Trial record 10 of 82 for:    "factor V Leiden thrombophilia" OR "Thrombophilia"

Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Psychotic Patients

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Silvia Hoirisch Clapauch, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01487291
First received: December 5, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

At the Thrombophilia Clinic of the Hospital Federal dos Servidores do Estado do Rio de Janeiro there is a high prevalence of acute psychotic episodes, which allows the investigators to raise the suspicion that the thrombotic tendency or hypofibrinolysis play a role in the onset of the disease. It is striking that most of these patients, after some time on anticoagulants, no longer need to take psychiatric medication.


Condition
Insulin Resistance
Thrombophilia
Psychosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Psychotic Patients

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Prevalence of hypofibrinolysis markers in psychotic patients [ Time Frame: One year ] [ Designated as safety issue: No ]
    The investigators' hypothesis is that a high prevalence of hypofibrinolysis markers will be probably found in psychotic patients.


Secondary Outcome Measures:
  • Prevalence of Clinical and Laboratory Markers of Hipofibrinolysis in Patients who Need Electroconvulsive Therapy [ Time Frame: 2013-2014 ] [ Designated as safety issue: No ]
    The investigators are assessing clinical and laboratory markers of plasminogen activator imbalance in psychiatric patients who require electroconvulsive therapy, specifically patients with major depressive disorders and schizophrenia.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psychotic patients
Inpatients and outpatients followed at Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, Brazil

Detailed Description:

If the thrombotic tendency plays a significant role in the etiology of psychosis, one would expect to find ischemic brain injuries in neuroimaging studies, but it does not happen. Therefore, if there is a correlation between thrombotic tendency-hypofibrinolysis and psychosis it is likely to occur at the biochemical level, such as in neuronal transmission.

The investigators hypothesis is that mechanisms that inhibit tissue plasminogen activator (t-PA) and therefore promote hypofibrinolysis, are directly or indirectly involved in the genesis of psychosis, because t-PA participates in neuronal plasticity and low t-PA levels are related to dementia.

Hypofibrinolysis due to t-PA inhibition can be seen in:

  • Insulin resistance, when the pancreas must produce large amounts of insulin and proinsulin by feedback. If pancreatic reserve is inadequate, the result is diabetes mellitus. If the response is adequate, proinsulin stimulates the production of PAI-1 (plasminogen activator inhibitor 1. PAI-1 inhibits the formation of plasmin, whose function is to dissolve fibrin which makes up the clot. Obesity, certain infections and inflammations potentiate insulin resistance.
  • Antiphospholipid antibody syndrome.
  • PAI-1 4G/5G or 4G/4G polymorphism.

Some hypofibrinolysis indicators are:

  • severe dysmenorrhea, because strong uterine contractions are necessary to expel undissolved clots.
  • PCOS because plasmin is required to activate some metalloproteinases involved in ovary remodelling.
  • early pregnancy losses, as some metalloproteinases involved in placental angiogenesis are activated by plasmin,
  • preeclampsia and eclampsia, as metalloproteinases that dissolve elastic fibers of the placental vessels, to create a low flow resistance, are activated by plasmin. Vascular endothelial growth factor (VEGF), a protein that restricts glomerular porosity, is also activated by plasmin,
  • sudden death and heart attack before age 50 in first degree relatives.

On physical exam, acanthosis, high body mass index, and in women, hirsutism and acne are indirect indicators of insulin resistance. Livedo suggest antiphospholipid antibody syndrome.

This study intents to investigate the prevalence of hypofibrinolysis markers, such as PAI-1 4G/5G and 4G/4G, protein S deficiency, antiphospholipid antibodies and prothrombin G20210A, in psychotic patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Psychotic patients treated at IPUB-UFRJ, comprising patients with schizophrenia, schizoaffective disorders, bipolar disorders (mania or depressive episodes, provided that the patient has shown an acute psychotic episode in the last two years.

Criteria

Inclusion Criteria:

  • Diagnosis of psychotic disorder by the Semi-structured Interview MINI 5.0.

Exclusion Criteria:

  • Inability to provide information.
  • Use of illicit drugs.
  • Infections such as cerebral toxoplasmosis in HIV seropositive or tertiary syphilis. Patients with recurrent syphilis will not be excluded, because false positive tests are common in antiphospholipid antibody syndrome.
  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: NCT01487291

Locations
Brazil
Institudo de Psiquiatria da UFRJ
Rio de Janeiro, Brazil, 22290-140
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Study Chair: Antonio E Nardi, MD, PhD Universidade Federal do Rio de Janeiro, Brazil
  More Information

No publications provided

Responsible Party: Silvia Hoirisch Clapauch, MD, Responsible for the HFSE Thrombophilia Clinic, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01487291     History of Changes
Other Study ID Numbers: UFRiodJaneiro
Study First Received: December 5, 2011
Last Updated: January 14, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal do Rio de Janeiro:
Thrombophilia tests
Hypofibrinolysis
Fibrinolysis

Additional relevant MeSH terms:
Insulin Resistance
Thrombophilia
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014