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Completed

NCT Number: NCT06071819

Clinical Markers of Panic and Generalized Anxiety Disorder

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Duration of Untreated Illness Mental Disorders Panic Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Structured Clinical Interview for DSM-5

Diagnostic Test

A structured interview will be administered to confirm the diagnosis reported in clinical charts

Primary outcomes

  1. Quantitative socio-demographic / clinical variables

    Time frame: Three months

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

  2. Sex

    Time frame: Three months

    Sex (male/female)

  3. Occupation

    Time frame: Three months

    Occupation (employed/unemployed)

  4. Pre-/post-onset Comorbidity

    Time frame: Three months

    Psychiatric and medical comorbidity

  5. Substance misuse

    Time frame: Three months

    Substance misuse

  6. Treatment

    Time frame: Three months

    Treatment, treatment discontinuation and side effects

  7. 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)

Secondary outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Collaborators

  • University of Milan

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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