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Hereditary AngioEdema, Neurobiology and Psychopathology

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02159430
Acronym
HAENP
Enrollment
35
Registered
2014-06-10
Start date
2014-11-30
Completion date
2015-05-31
Last updated
2014-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Hereditary AngioEdema

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.

Interventions

OTHERClinical and psychopathological assessment of HAE patients

Sponsors

University Hospital, Catania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Multivariate linear regression analysis of HAE clinical status and psychometric parametersFirst assessment

Countries

Italy

Contacts

Primary ContactGiuseppe Minutolo, MD, PhD
giuseppeminutolo@hotmail.com+39 0953782791
Backup ContactFrancesca Magnano S. Lio, MD
francesca.magnanosanlio@gmail.com+39 0953782470

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026