Hereditary AngioEdema, Neurobiology and Psychopathology

• Conditions: Hereditary AngioEdema; Depression; Anxiety

• Registration Number: NCT02159430
• Lead Sponsor: University Hospital, Catania

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-10
• Last Update Posted: 2014-06-10
• Study Start: 2014-11
• Primary Completion: 2015-02
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multivariate linear regression analysis of HAE clinical status and psychometric parameters	First assessment

Trial Locations

Locations (1)

UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele; 🇮🇹 Catania, Italy