Clinical Markers of Panic and Generalized Anxiety Disorder

Sponsor
University of Milano Bicocca (Other)
Overall Status
Completed
CT.gov ID
NCT06071819
Collaborator
University of Milan (Other)
290
1
3
97

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Structured Clinical Interview for DSM-5

Study Design

Study Type:
Observational
Actual Enrollment :
290 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Generalized Anxiety Disorder and Panic Disorder: Differences in Clinical Manifestation and Prognosis, a Multicenter Study
Actual Study Start Date :
Aug 1, 2022
Actual Primary Completion Date :
Oct 31, 2022
Actual Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Quantitative socio-demographic / clinical variables [Three months]

    Age (years), age at onset (years), duration of illness (years), duration of treatment (years)

  2. Sex [Three months]

    Sex (male/female)

  3. Occupation [Three months]

    Occupation (employed/unemployed)

  4. Pre-/post-onset Comorbidity [Three months]

    Psychiatric and medical comorbidity

  5. Substance misuse [Three months]

    Substance misuse

  6. Treatment [Three months]

    Treatment, treatment discontinuation and side effects

  7. 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)

Secondary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori Monza MB Italy 20900

Sponsors and Collaborators

  • University of Milano Bicocca
  • University of Milan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alice Caldiroli, Psychiatrist, University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT06071819
Other Study ID Numbers:
  • GAD-PD-3955
First Posted:
Oct 10, 2023
Last Update Posted:
Oct 10, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 10, 2023