Hereditary AngioEdema, Neurobiology and Psychopathology

Depression Clinical Trial

— HAENP  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02159430
• Other study ID #: UHCatania1
• 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

• Angioedema
• Anxiety
• Depression
• Hereditary AngioEdema

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