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Hereditary AngioEdema, Neurobiology and Psychopathology (HAENP)

G

G. Rodolico - San Marco Polyclinic University Hospital

Status

Unknown

Conditions

Hereditary AngioEdema
Depression
Anxiety

Treatments

Other: Clinical and psychopathological assessment of HAE patients

Study type

Observational

Funder types

Other

Identifiers

NCT02159430
UHCatania1

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

35 participants in 1 patient group

HereditaryAngioEdema
Description:
Patients from the Eastern Sicily HAE register
Treatment:
Other: Clinical and psychopathological assessment of HAE patients

Trial contacts and locations

1

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Central trial contact

Francesca Magnano S. Lio, MD; Giuseppe Minutolo, MD, PhD

Data sourced from clinicaltrials.gov

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