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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02159430
Other study ID # UHCatania1
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 5, 2014
Last updated June 5, 2014
Start date November 2014
Est. completion date May 2015

Study information

Verified date June 2014
Source University Hospital, Catania
Contact Giuseppe Minutolo, MD, PhD
Phone +39 0953782791
Email giuseppeminutolo@hotmail.com
Is FDA regulated No
Health authority Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date May 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
Clinical and psychopathological assessment of HAE patients


Locations

Country Name City State
Italy UOPI of psychiatry - Department of clinical and molecular biomedicine - AOU Policlinico-Vittorio Emanuele Catania

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Catania

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Multivariate linear regression analysis of HAE clinical status and psychometric parameters First assessment No
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