Clinical Markers of Panic and Generalized Anxiety Disorder

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder; Panic Disorder; Duration of Untreated Illness
• Intervention / Treatment: Diagnostic test: Structured Clinical Interview for DSM-5

• Study Type: Observational
• Enrollment (Actual): 290

Contacts and Locations

Study Locations

• Italy
  • MB
    • Monza, MB, Italy, 20900
      • University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Outpatients suffering from PD or GAD identified from medical records in the pre-pandemic period (2016-2019).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Generalized Anxiety Disorder (GAD); Patients affected by GAD	Diagnostic test: Structured Clinical Interview for DSM-5; A structured interview will be administered to confirm the diagnosis reported in clinical charts
Panic Disorder (PD); Patients affected by Panic Disorder	Diagnostic test: Structured Clinical Interview for DSM-5; A structured interview will be administered to confirm the diagnosis reported in clinical charts

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Collaborators: University of Milan
• Investigators: Principal Investigator: Alice Caldiroli, Doctor, University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Estimated): October 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: GAD-PD-3955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No