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Clinical Trials/NCT06071819
NCT06071819
Completed
Not Applicable

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

University of Milano Bicocca1 site in 1 country290 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Generalized Anxiety Disorder
Sponsor
University of Milano Bicocca
Enrollment
290
Locations
1
Primary Endpoint
Substance misuse
Status
Completed
Last Updated
2 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
October 31, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Alice Caldiroli

Psychiatrist

University of Milano Bicocca

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Substance misuse

Time Frame: Three months

Substance misuse

Dichotomous socio-demographic / clinical variables

Time Frame: 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)

Sex

Time Frame: Three months

Sex (male/female)

Occupation

Time Frame: Three months

Occupation (employed/unemployed)

Treatment

Time Frame: Three months

Treatment, treatment discontinuation and side effects

Quantitative socio-demographic / clinical variables

Time Frame: Three months

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

Pre-/post-onset Comorbidity

Time Frame: Three months

Psychiatric and medical comorbidity

Secondary Outcomes

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

Study Sites (1)

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