Clinical Markers of Panic and Generalized Anxiety Disorder

Completed

• Conditions: Generalized Anxiety Disorder; Panic Disorder; Duration of Untreated Illness
• Interventions: Diagnostic Test: Structured Clinical Interview for DSM-5

• Registration Number: NCT06071819
• Lead Sponsor: University of Milano Bicocca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Primary Completion: 2022-10-31
• Study Completion: 2022-10-31
• Study First Submitted: 2023-01-05
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Panic Disorder (PD)	Structured Clinical Interview for DSM-5	Patients affected by Panic Disorder
Generalized Anxiety Disorder (GAD)	Structured Clinical Interview for DSM-5	Patients affected by GAD

Primary Outcome Measures

Name	Time	Method
Occupation	Three months	Occupation (employed/unemployed)
Treatment	Three months	Treatment, treatment discontinuation and side effects
Sex	Three months	Sex (male/female)
Substance misuse	Three months	Substance misuse
Dichotomous socio-demographic / clinical variables	Three months	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)
Quantitative socio-demographic / clinical variables	Three months	Age (years), age at onset (years), duration of illness (years), duration of treatment (years)
Pre-/post-onset Comorbidity	Three months	Psychiatric and medical comorbidity

Secondary Outcome Measures

Name	Time	Method
Duration of untreated illness (DUI) in months = time between the onset of PD and the first appropriate pharmacological treatment.	Three months	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)

Trial Locations

Locations (1)

University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori; 🇮🇹 Monza, MB, Italy