A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder

Who can take part

• Male or female participants aged 19 years or older and under 65 years at the time of providing written informed consent
• Participants who meet the DSM-5 diagnostic criteria for panic disorder or have a diagnosis corresponding to one or more of the following ICD-10 codes:; F41.0: Panic disorder / panic attack / panic state F40.0: Agoraphobia / agoraphobia without a history of panic disorder / panic disorder with agoraphobia 3. Participants with a score on the Korean version of the Panic Disorder Severity Scale-Self Report (PDSS-SR) meeting the following criteria according to the presence or absence of agoraphobia: Without agoraphobia: ≥6 points With agoraphobia: ≥8 points 4. Participants who have no difficulty reading and writing Korean. 5. Participants who have no difficulty using a smartphone application. 6. Participants who, after receiving sufficient information about the clinical trial and fully understanding the information provided, voluntarily decide to participate, provide written informed consent, and agree to comply with the study requirements and instructions

Who cannot take part

• Participants who have a lifetime history of any of the following psychiatric diagnoses as of the date of written informed consent; : Schizophrenia spectrum disorders or substance use disorders*; *However, participants with alcohol use disorder (AUD) may be included if the disorder is classified as mild according to the DSM-5 diagnostic criteria, they have no history of hospitalization or emergency department visits due to alcohol-related problems within the 3 months prior to providing written informed consent, and the investigator determines, based on medical judgment, that the condition would not interfere with the participant's ability to comply with the requirements of the clinical trial
• Participants who have attempted suicide within the 3 months prior to providing written informed consent and are assessed by a psychiatrist as being at high risk of suicide
• Participants who have newly initiated another cognitive behavioral therapy (CBT) within the 3 months prior to providing written informed consent or who are currently receiving another CBT intervention, including CBT for panic disorder or any other condition
• Participants who, within the 4 weeks prior to screening, have had a change in the type, dosage, or dosing regimen of any medication they are taking; However, participants meeting any of the following conditions may participate in the clinical trial:
• Background therapy: Participants taking psychiatric medication for the management of panic symptoms may participate if the type, dosage, and dosing regimen of the medication have remained unchanged for at least 4 weeks prior to screening
• Pro re nata (PRN) medication: Participants using PRN medication for the relief of acute panic symptoms may participate even if there has been a change in the type, dosage, or dosing regimen of such PRN medication within the 4 weeks prior to screening
• Medications for transient symptoms: Participants who have taken short-term medications within the 4 weeks prior to screening for the relief of transient symptoms, such as a common cold, mild pain, or indigestion, that are not expected to directly affect the assessment of panic symptoms may participate
• Participants who have any of the following psychiatric conditions at the time of providing written informed consent; : Schizophrenia spectrum disorders, a manic episode, a major depressive episode, or substance use disorders*
• Participants who, at the time of providing written informed consent, have a medical condition that is uncontrolled or severe enough to require hospitalization
• Participants with visual or hearing impairment, or cognitive impairment (e.g., intellectual disability or dementia)
• Non-psychiatric medications:
• Medications for chronic medical conditions: Participants taking non-psychiatric medications for the treatment of underlying chronic medical conditions, such as hypertension, diabetes mellitus, or dyslipidemia, that are not expected to directly affect the assessment of panic symptoms may participate if the dosage and dosing regimen have remained unchanged for at least 4 weeks
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• Participants who, in the investigator's judgment, are considered unsuitable for participation in this clinical trial