Clinical Markers of Panic and Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

Generalized Anxiety Disorder and Panic Disorder: Differences in Clinical Manifestation and Prognosis, a Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06071819
• Other study ID #: GAD-PD-3955
• Status: Completed
• Start date: August 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2023
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to compare socio-demographic and clinical features in patients affected by Generalized Anxiety Disorder (GAD) and by Panic Disorder (PD). The main questions it aims to answer are:

• which socio-demographic/clinical markers are associated to GAD or PD diagnosis?

• which factors are associated with a longer duration of untreated illness (DUI) in GAD and in PD? Participants will signed a written informed consent and socio-demographic/clinical variables will be retrospectively collected. Researchers will compare GAD and PD groups in terms of socio-demographic and clinical features, including DUI, to better characterize the two disorders and to investigate factors associated to a longer DUI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65 years;

• ability and willing to give informed consent;

• fluency in Italian language;

• diagnosis of GAD or PD according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, 5th edition.

Exclusion Criteria:

• intellectual disability;

• lack of clinical and socio-demographic information;

• patients treated for less than three months in the outpatient clinics for the impossibility of a comprehensive collection of clinical variables.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder
• Panic Disorder

Intervention

Diagnostic Test:
• Structured Clinical Interview for DSM-5
A structured interview will be administered to confirm the diagnosis reported in clinical charts

Locations

Country	Name	City	State
Italy	University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori	Monza	MB

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantitative socio-demographic / clinical variables	Age (years), age at onset (years), duration of illness (years), duration of treatment (years)	Three months
Primary	Sex	Sex (male/female)	Three months
Primary	Occupation	Occupation (employed/unemployed)	Three months
Primary	Pre-/post-onset Comorbidity	Psychiatric and medical comorbidity	Three months
Primary	Substance misuse	Substance misuse	Three months
Primary	Treatment	Treatment, treatment discontinuation and side effects	Three months
Primary	Dichotomous socio-demographic / clinical variables	Multiple family history of psychiatric disorders (yes/no), pre- and post-onset psychiatric poly-comorbidities (yes/no), presence of personality disorder (yes/no), pre- and post-onset poly-substance misuse (yes/no), pre- and post-onset medical poly-comorbidities (yes/no), suicide attempts (yes/no), hospitalizations (yes/no), poly-therapy (yes/no), presence of poly-side effects (yes/no), presence of lifetime psychotherapy (yes/no)	Three months
Secondary	Duration of untreated illness (DUI) in months = time between the onset of PD and the first appropriate pharmacological treatment.	Factors associated to DUI among GAD and PD groups. Information about DUI have been registered according to what the patient reported (clinical records and structured interviews)	Three months