Hereditary AngioEdema, Neurobiology and Psychopathology

NCT ID: NCT02159430

Last Updated: 2014-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.

Detailed Description

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Conditions

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Hereditary AngioEdema Anxiety Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HereditaryAngioEdema

Patients from the Eastern Sicily HAE register

Clinical and psychopathological assessment of HAE patients

Intervention Type OTHER

Interventions

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Clinical and psychopathological assessment of HAE patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Diagnosis of HAE

Exclusion Criteria

* Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
* Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
* Ongoing allergies.
* Night work over the past 15 days.
* Vigorous physical activity or alcohol consumption (the day before the assessment).
* Women in follicular phase of menstrual cycle.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Catania

OTHER

Sponsor Role lead

Responsible Party

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Prof. Eugenio Aguglia

Full Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele

Catania, Catania, Italy

Site Status

Countries

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Italy

Central Contacts

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Giuseppe Minutolo, MD, PhD

Role: CONTACT

+39 0953782791

Francesca Magnano S. Lio, MD

Role: CONTACT

+39 0953782470

Facility Contacts

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Giuseppe Minutolo, MD, PhD

Role: primary

Francesca Magnano S. Lio, MD

Role: backup

Other Identifiers

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UHCatania1

Identifier Type: -

Identifier Source: org_study_id

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