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AzTrials

Panic DisorderIRPANCT06773585

Investigations of Factors Associated With Treatment Response and Prognosis in Anxiety Disorders

An observational study of Panic Disorder, run by Kangbuk Samsung Hospital at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to build a comprehensive brain and behavioral dataset on anxiety disorders and identify clinical factors related to treatment response and prognosis in patients with anxiety disorders. Read more about this study

Who is it for?
Ages 19 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Panic Disorder
What is being tested?
Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI
How many people
185 participants
Where
1 siteSouth Korea
Study dates
15 May 2025to 15 Dec 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population consists of the anxiety behavior group and the healthy control group. 1. Anxiety Behavior Group Adults aged 19 to 60 who received a consultation at the Department of Psychiatry, Kangbuk Samsung Hospital, and were deemed eligible for study participation by the principal investigator. 2. Healthy Control Group Adults aged 19 to 60 voluntarily recruited through a notice posted on the bulletin board at Kangbuk Samsung Hospital.

Who may be able to join

  • Anxiety Behavior Group
  • Adults aged 19-60 years.
  • Diagnosed with an anxiety disorder based on DSM-5 diagnostic criteria, evaluated by a board-certified psychiatrist.
  • Individuals who fully understand the study's purpose and process and provide informed consent.
  • Healthy Control Group
  • Adults aged 19-60 years.
  • Individuals who report no psychiatric symptoms and are not taking any psychotropic medications.
  • Individuals who fully understand the study's purpose and process and provide informed consent.

Who cannot join

  • Anxiety Behavior Group
  • Individuals unable to read the consent form.
  • Individuals with difficulty using virtual reality devices.
  • Individuals with a history of epileptic seizures, brain injuries, or neurological disorders.
  • Individuals with severe physical illnesses (e.g., cancer, tuberculosis, severe cardiovascular diseases).
  • Individuals with substance or alcohol use disorders.
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  • Individuals with pacemakers or implanted metallic devices.
  • Pregnant individuals or those in vulnerable environments, such as institutional employees.
  • Healthy Control Group
  • Additionally, individuals with any current or past psychiatric disorders are excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Junhyung Kim, Clinical Assistant Professor contact

+82-2-2001-2431

jihndy.kim@samsung.com

Jeongyeon Woo, Clinical Research Coordinator contact

+82-2-2001-1805

South Korea1 site
  • Kangbuk Samsung Medical Center

    Seoul, Jongno-gu, 03181

    Junhyung Kim, Clinical Assistant Professor, +82-2-2001-2431, jihndy.kim@samsung.com

Other trials in South Korea

About this study

The purpose of this study is to build a comprehensive brain and behavioral dataset on anxiety disorders and identify clinical factors related to treatment response and prognosis in patients with anxiety disorders. By conducting an integrated analysis of clinical features (phenotypes), comorbid conditions, virtual reality (VR)-based behavioral data, electroencephalogram (EEG) data, and MRI-based data in patients undergoing treatment for anxiety disorders and healthy controls, this study aims to enhance the understanding of the pathophysiology of anxiety disorders and establish a foundation for precision medicine.

Anxiety disorders significantly impair quality of life by inducing irrational fear and apprehension even in everyday situations. Over the past few years, the prevalence of anxiety disorders and associated medical expenses have surged, escalating the societal and economic burden. However, the current diagnostic system, DSM-5, relies on symptom-based approaches, which often lead to heterogeneity within the same diagnostic category. This limitation hinders the accurate prediction of treatment response and the design of optimal therapeutic strategies. To address these issues, the U.S. National Institute of Mental Health (NIMH) proposed the Research Domain Criteria (RDoC). RDoC is a multidimensional framework that integrates behavioral, psychological, and neurological data to facilitate the development of treatment strategies rooted in pathophysiology. Nonetheless, the acquisition of objective and reliable assessment data remains a challenge due to the inherent characteristics of mental disorders.

Read more

Virtual reality (VR) technology has emerged as a promising solution to overcome these limitations. VR enables the creation of immersive 3D environments that can elicit anxiety-related behaviors and precisely evaluate them in controlled settings. It also allows data collection in scenarios that closely resemble real-life situations while offering advantages such as repeatability and ease of use. Combining behavioral data collected in VR environments with EEG data can provide a more detailed understanding of the neurophysiological representations underlying anxiety behaviors. EEG, as a biomarker reflecting neural activity in real time, facilitates intuitive and effective analyses. Moreover, MRI-based brain imaging plays a critical role in identifying structural and functional connectivity differences between anxiety disorder patients and healthy controls. It offers crucial insights into the biomarkers that predict treatment outcomes and prognosis.

By integrating these data, this study seeks to uncover the key factors influencing treatment response and prognosis in patients with anxiety disorders.

Read the detailed description

[ Observational Parameters, Clinical and Laboratory Assessments ]

Participants in the anxiety behavior group will undergo four visits (initial evaluation, 2-month follow-up, 6-month follow-up, and 12-month follow-up), while the healthy control group will attend two visits (initial evaluation and 12-month follow-up). As the evaluations at 2 and 12 months consist solely of basic clinical assessments, they may be conducted via remote methods, such as telephone interviews or online surveys (e.g., Google Forms).

Initial Evaluation:

The initial evaluation includes approximately one hour of clinical and psychiatric symptom evaluations, a 30-minute virtual reality-based behavioral assessment, and a 40-minute brain imaging session.

  1. Clinical assessment: Includes the assessment of sociodemographic factors (e.g., gender, age, education level, marital status, occupation, alcohol and smoking habits, height, and weight) and anxiety disorder-related medical history (e.g., symptom patterns and duration, psychiatric treatment history, and family history).
  2. Evaluation of anxiety symptoms and associated psychiatric conditions: Utilizes various standardized scales and questionnaires, such as PDSS, LSAS, GAD, DASS, IUS, ASI, BAS, PANAS, neurocognitive tests, SSQ, and STRAIN.
  3. Virtual Reality-Based Behavioral Assessment: Gathers biometric signals and EEG data in response to stimuli presented in virtual environments.
  4. Brain MRI:

Conducted using a 3.0T Philips Ingenia CX scanner, acquiring T1-weighted 3D coronal structural images, resting-state functional MRI, and diffusion-weighted images.

Follow-Up Assessments:

Participants in the anxiety behavior group will undergo assessments of four measures - PDSS, LSAS, GAD, and DASS - at 2 and 12 months. At 6 months, they will undergo assessments covering (2) the evaluation of anxiety symptoms and associated psychiatric characteristics, (3) virtual reality-based behavioral assessments, and (4) brain MRI, as conducted at baseline.

Healthy control participants will undergo the same four assessments (PDSS, LSAS, GAD, DASS) evaluating anxiety symptoms and associated psychiatric characteristics at 12 months at the Department of Psychiatry of our institution.

At 12 months, both the anxiety behavior group and the healthy control group will additionally complete the collection of clinical evaluation items (1), excluding sex and age.

[ Data Analysis and Statistical Methods ] The results of the initial evaluation will be used to develop a three-group classification model (healthy controls vs. response vs. no-response) based on clinical evaluation outcomes at 2, 6, and 12 months. Participants will be categorized into remission and no-remission groups based on a ≥40% reduction in the PDSS score at the 2, 6, and 12 months follow-up assessments, allowing for a detailed understanding of the treatment effects over time.

Additionally, a regression model will be constructed to analyze the magnitude of changes in clinical evaluation outcomes.

This study will test various machine learning models, including classification methods like Dummy, Logistic Regression, Support Vector Machine, and Boosting models (eXtreme Gradient Boosting, CatBoost), using k-fold cross-validation to evaluate performance through accuracy, balanced accuracy, and F1 scores. Regression models, including Dummy Regressor, Linear Regression, Support Vector Regression, Multilayer Perceptron, and Bayesian Regression, will be assessed using Mean Squared Error (MSE), Mean Absolute Error (MAE), and R² scores.

The pathophysiology of anxiety disorder will be explored using resting-state functional brain MRI data, with cross-sectional and longitudinal comparisons of anxiety behavior groups and healthy controls. Network analysis will be conducted to identify significant brain connections, with false discovery rate (FDR) correction applied to control for multiple comparisons.

Conditions
Panic Disorder
Being tested
Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI
Keywords
panic disorder, anxiety disorder, panic attack
Medical subject headings
Panic Disorder, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRIDiagnostic test

    This study is a minimal-risk study involving non-invasive, non-pharmacological interventions. Participants will continue receiving their usual medication or counseling treatments as part of their routine care during the study.

    When participants come to the hospital for assessments, they will engage in clinical assessments and complete questionnaires over a period of 1-2 hours, undergo MRI scans, and participate in virtual environment-based behavioral assessments. They will have the option to take breaks during the assessments and can withdraw from the study at any time without providing a reason.

Study groups in NCT06773585
Study groupRoleWhat they receive
Anxiety Behavior GroupParticipants diagnosed with an anxiety disorder based on DSM-5 diagnostic criteria, evaluated by a board-certified psychiatrist. The principal investigator, a board-certified psychiatrist, will conduct the following diagnostic assessments and differential diagnoses to screen eligible participants according to the inclusion and exclusion criteria. Anxiety disorders will be diagnosed using the Structured Clinical Interview for DSM-5 Disorders, Clinical Version (SCID-5-CV; First et al., 2016), and other major psychiatric conditions will be ruled out using the Mini International Neuropsychiatric Interview (MINI; Lecrubier et al., 1997). Participants will undergo four visits (initial evaluation, 2-month follow-up, 6-month follow-up, and 12-month follow-up).
Receives: Diagnostic Test: Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI
Healthy Control GroupIndividuals who report no psychiatric symptoms and are not taking any psychotropic medications. Participants will undergo two visits (initial evaluation and 12-month follow-up).
Receives: Diagnostic Test: Psychiatric scale assessments, VR-Based Behavioral Assessment, Brain MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Panic Disorder Severity Scale (PDSS)

    The PDSS (Panic Disorder Severity Scale) is a tool used to assess the severity of panic disorder symptoms. It consists of 7 items that measure the frequency, intensity, and impact of panic attacks on daily life. The scale uses a 5-point Likert scale, ranging from "Not at all" (0 points) to "Severely" (4 points). The total score ranges from 0 to 28, with higher scores indicating more frequent and intense panic attacks.

    Participants will be classified into remission and no-remission groups based on a ≥40% reduction in the PDSS score at the 2-month, 6-month, and 12-month follow-up assessments.

    Measured: At the initial, 2-month, 6-month, and 12-month time points

Secondary outcomes (3)
  1. 7-item Generalized Anxiety Disorder Scale (GAD)

    The GAD-7 (Generalized Anxiety Disorder-7) is a tool used to assess the severity of generalized anxiety disorder symptoms. It consists of 7 items that measure the frequency and intensity of anxiety-related symptoms. The scale uses a 4-point Likert scale, ranging from "Not at all" (0 points) to "Nearly every day" (3 points). The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. A higher score suggests a worse outcome, meaning more frequent and intense anxiety.

    Measured: At the initial, 2-month, 6-month, and 12-month time points

  2. Depression, Anxiety, Stress Scale (DASS)

    The DASS-21 (Depression Anxiety Stress Scale-21) is a psychological tool developed by Henry and Crawford to assess the severity of depression, anxiety, and stress. It consists of 21 items, with 7 items for each symptom. The scale uses a 4-point Likert scale ranging from "Did not apply at all" (0 points) to "Applied very much or most of the time" (3 points). The depression, anxiety, and stress scores each range from 0 to 21, with higher scores indicating more severe symptoms. Depression severity is categorized as Normal (0-4), Mild Depression (5-6), Moderate Depression (7-10), Severe Depression (11-13), and Very Severe Depression (≥14). Anxiety and stress are similarly assessed, with higher scores indicating more severe symptoms.

    Measured: At the initial, 2-month, 6-month, and 12-month time points

  3. Liebowits Social Anxiety Scale (LSAS)

    The Liebowitz Social Anxiety Scale (LSAS) is a tool used to assess the severity of social anxiety disorder symptoms, consisting of 24 items divided into two sections: 13 items related to fear and 11 items related to avoidance in social situations. Each item is rated using a 4-point Likert scale: for fear, the scale ranges from 0 (Not at all) to 3 (Severely), and for avoidance, it ranges from 0 (Never) to 3 (Often). The total score ranges from 0 to 144, with higher scores indicating more severe symptoms. The score interpretation is as follows: 0-29 indicates no social anxiety, 30-49 represents mild social anxiety, 50-64 is moderate social anxiety, 65-79 is marked social anxiety, 80-94 is severe social anxiety, and ≥95 signifies very severe social anxiety.

    Measured: At the initial, 2-month, 6-month, and 12-month time points

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start15 May 2025 (estimated)
  3. Primary completion15 May 2029 (estimated)
  4. Study completion15 Dec 2029 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
185 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773585
Sponsor's protocol ID
KBSMC IRB 2024-10-018-002
Acronym
IRPA
Status last verified
Apr 2025
First submitted
8 Jan 2025
Last updated
30 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Panic Disorder, run by Kangbuk Samsung Hospital at 1 site in South Korea.

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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 30 Apr 2025. 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 South Korea. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junhyung Kim, Clinical Assistant Professor (+82-2-2001-2431, jihndy.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Panic Disorder Severity Scale (PDSS) (time frame: At the initial, 2-month, 6-month, and 12-month time points). 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 30 Apr 2025.

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