NCT01487291

Brief 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. It is striking that most of these patients, after some time on anticoagulants, no longer need to take psychiatric medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

4 months

First QC Date

December 5, 2011

Last Update Submit

December 15, 2014

Conditions

Keywords

Thrombophilia testsHypofibrinolysisFibrinolysis

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (1)

  • Prevalence of Clinical and Laboratory Markers of Hypofibrinolysis in Patients who Need Electroconvulsive Therapy

    2013-2014

Study Arms (1)

Psychotic patients

Inpatients and outpatients followed at Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro, Brazil

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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. Age-matched control group

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder by the Semi-structured Interview MINI 5.0.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institudo de Psiquiatria da UFRJ

Rio de Janeiro, Rio de Janeiro, 22290-140, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 24108470BACKGROUND
  • Hoirisch-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.

    PMID: 24113086BACKGROUND
  • Hoirisch-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.

MeSH Terms

Conditions

Insulin ResistanceThrombophiliaPsychotic Disorders

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Antonio E Nardi, MD, PhD

    Universidade Federal do Rio de Janeiro, Brazil

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Responsible for the HFSE Thrombophilia Clinic

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

January 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations