Generalized Anxiety DisorderNCT06071819
Clinical Markers of Panic and Generalized Anxiety Disorder
An observational study of Generalized Anxiety Disorder and Panic Disorder, run by University of Milano Bicocca at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder, Panic Disorder, Duration of Untreated Illness
- What is being tested?
- Structured Clinical Interview for DSM-5
- How many people
- 290 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2022to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients suffering from PD or GAD identified from medical records in the pre-pandemic period (2016-2019).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
About this study
Official title: 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.
- Being tested
- Structured Clinical Interview for DSM-5
- Medical subject headings
- Generalized Anxiety Disorder, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Clinical Interview for DSM-5Diagnostic test
A structured interview will be administered to confirm the diagnosis reported in clinical charts
| Study group | Role | What they receive |
|---|---|---|
| Generalized Anxiety Disorder (GAD) | Patients affected by GAD Receives: Diagnostic Test: Structured Clinical Interview for DSM-5 | |
| Panic Disorder (PD) | Patients affected by Panic Disorder Receives: Diagnostic Test: Structured Clinical Interview for DSM-5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative socio-demographic / clinical variables
Age (years), age at onset (years), duration of illness (years), duration of treatment (years)
Measured: Three months
Sex
Sex (male/female)
Measured: Three months
Occupation
Occupation (employed/unemployed)
Measured: Three months
Pre-/post-onset Comorbidity
Psychiatric and medical comorbidity
Measured: Three months
Substance misuse
Substance misuse
Measured: Three months
Treatment
Treatment, treatment discontinuation and side effects
Measured: 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)
Measured: Three months
Secondary outcomes (1)
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)
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Aug 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Alice Caldiroli, University of Milano Bicocca
- Investigators
- Alice Caldiroli, Doctor, Principal investigator, University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071819
- Sponsor's protocol ID
- GAD-PD-3955
- Status last verified
- Oct 2023
- First submitted
- 5 Jan 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalized Anxiety Disorder and Panic Disorder: Differences in Clinical Manifestation and Prognosis, a Multicenter Study
- ClinicalTrials.gov ID
- NCT06071819
- Acronym / sponsor ID
- GAD-PD-3955
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generalized Anxiety Disorder (GAD) | – | Diagnostic Test: Structured Clinical Interview for DSM-5Patients affected by GAD |
| Panic Disorder (PD) | – | Diagnostic Test: Structured Clinical Interview for DSM-5Patients affected by Panic Disorder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients suffering from PD or GAD identified from medical records in the pre-pandemic period (2016-2019).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Clinical Interview for DSM-5A structured interview will be administered to confirm the diagnosis reported in clinical charts | Diagnostic test | Generalized Anxiety Disorder (GAD), Panic Disorder (PD) |
Primary outcome
Quantitative socio-demographic / clinical variables
Time frame: Three months
Age (years), age at onset (years), duration of illness (years), duration of treatment (years)
Sex
Time frame: Three months
Sex (male/female)
Occupation
Time frame: Three months
Occupation (employed/unemployed)
Pre-/post-onset Comorbidity
Time frame: Three months
Psychiatric and medical comorbidity
Substance misuse
Time frame: Three months
Substance misuse
Treatment
Time frame: Three months
Treatment, treatment discontinuation and side effects
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)
1 secondary outcome
Duration of untreated illness (DUI) in months = time between the onset of PD and the first appropriate pharmacological treatment.
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice Caldiroli, Doctor principal investigator
University of Milano Bicocca - Fondazione IRCCS San Gerardo dei Tintori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Anxiety Disorder and Panic Disorder, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative socio-demographic / clinical variables (time frame: Three months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.