Insulin ResistanceNCT01487291
Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Psychotic Patients
An observational study of Insulin Resistance and Thrombophilia, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Thrombophilia, Psychosis
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2013to May 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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. Age-matched control group
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder by the Semi-structured Interview MINI 5.0.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Institudo de Psiquiatria da UFRJ
Rio de Janeiro, Rio de Janeiro, 22290-140
About this study
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.
Read the 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.
- Conditions
- Insulin Resistance, Thrombophilia, Psychosis
- Keywords
- Thrombophilia tests, Hypofibrinolysis, Fibrinolysis
- Medical subject headings
- Insulin Resistance, Thrombophilia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Psychotic patients | Inpatients and outpatients followed at Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, Brazil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hypofibrinolysis markers in psychotic patients
The investigators' hypothesis is that a high prevalence of hypofibrinolysis markers will be probably found in psychotic patients.
Measured: One year
Secondary outcomes (1)
Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Patients who Need Electroconvulsive Therapy
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.
Measured: 2013-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Responsible party
- Principal investigator, Silvia Hoirisch Clapauch, Universidade Federal do Rio de Janeiro
- Investigators
- Antonio E Nardi, MD, PhD, Study chair, Universidade Federal do Rio de Janeiro, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487291
- Sponsor's protocol ID
- UFRiodJaneiro
- Status last verified
- Dec 2014
- First submitted
- 5 Dec 2011
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hoirisch-Clapauch S, Nardi AE. Multiple roles of tissue plasminogen activator in schizophrenia pathophysiology. Semin Thromb Hemost. 2013 Nov;39(8):950-4. doi: 10.1055/s-0033-1357505. Epub 2013 Oct 9.
PubMed 24108470Hoirisch-Clapauch S, Mezzasalma MA, Nardi AE. Pivotal role of tissue plasminogen activator in the mechanism of action of electroconvulsive therapy. J Psychopharmacol. 2014 Feb;28(2):99-105. doi: 10.1177/0269881113507639. Epub 2013 Oct 9.
PubMed 24113086Hoirisch-Clapauch S, Nardi AE. Markers of low activity of tissue plasminogen activator/plasmin are prevalent in schizophrenia patients. Schizophr Res. 2014 Oct;159(1):118-23. doi: 10.1016/j.schres.2014.08.011. Epub 2014 Sep 7.
PubMed 25205258
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Psychotic Patients
- ClinicalTrials.gov ID
- NCT01487291
- Acronym / sponsor ID
- UFRiodJaneiro
- Conditions
- Insulin Resistance, Thrombophilia, Psychosis
- Keywords
- Thrombophilia tests, Hypofibrinolysis, Fibrinolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Rio de Janeiro State Research Supporting Foundation (FAPERJ)
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 7 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychotic patients | – | –Inpatients and outpatients followed at Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, Brazil |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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. Age-matched control group
Key inclusion criteria (1 listed)
- Diagnosis of schizophrenia or schizoaffective disorder by the Semi-structured Interview MINI 5.0.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of hypofibrinolysis markers in psychotic patients
Time frame: One year
The investigators' hypothesis is that a high prevalence of hypofibrinolysis markers will be probably found in psychotic patients.
1 secondary outcome
Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Patients who Need Electroconvulsive Therapy
Time frame: 2013-2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Background: PubMed 24108470Hoirisch-Clapauch S, Nardi AE. Multiple roles of tissue plasminogen activator in schizophrenia pathophysiology. Semin Thromb Hemost. 2013 Nov;39(8):950-4. doi: 10.1055/s-0033-1357505. Epub 2013 Oct 9.
- Background: PubMed 24113086Hoirisch-Clapauch S, Mezzasalma MA, Nardi AE. Pivotal role of tissue plasminogen activator in the mechanism of action of electroconvulsive therapy. J Psychopharmacol. 2014 Feb;28(2):99-105. doi: 10.1177/0269881113507639. Epub 2013 Oct 9.
- Results publication: PubMed 25205258Hoirisch-Clapauch S, Nardi AE. Markers of low activity of tissue plasminogen activator/plasmin are prevalent in schizophrenia patients. Schizophr Res. 2014 Oct;159(1):118-23. doi: 10.1016/j.schres.2014.08.011. Epub 2014 Sep 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio E Nardi, MD, PhD study chair
Universidade Federal do Rio de Janeiro, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Thrombophilia, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 3 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: finished, as of the sponsor's last update on 16 Dec 2014. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypofibrinolysis markers in psychotic patients (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01487291, which also lists 3 linked publications.
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 16 Dec 2014.