Hereditary AngioEdema, Neurobiology and Psychopathology

NCT02159430 | Unknown

• 1 other identifier: UHCatania1
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hereditary AngioEdema; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Multivariate linear regression analysis of HAE clinical status and psychometric parameters

  First assessment

Study Arms (1)

HereditaryAngioEdema

Patients from the Eastern Sicily HAE register

Other: Clinical and psychopathological assessment of HAE patients

Interventions

Clinical and psychopathological assessment of HAE patients OTHER

HereditaryAngioEdema

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This population-based cross-sectional study will include all Hereditary AngioEdema (HAE) patients from the Eastern Sicily HAE register.

You may qualify if:

• Diagnosis of HAE

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Catania: lead

Study Sites (1)

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

Catania, Catania, 95024, Italy

Location

MeSH Terms

Conditions

Angioedemas, Hereditary; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Giuseppe Minutolo, MD, PhD

CONTACT

+39 0953782791; giuseppeminutolo@hotmail.com

Francesca Magnano S. Lio, MD

CONTACT

+39 0953782470; francesca.magnanosanlio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Psychiatry

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 10, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

IT (1)