None listed
Conditions
Interventions
Medical Device : Investigational Device:
The investigational device is a software-based medical device designed to improve panic symptoms in patients with panic disorder. It analyzes digital phenotypi
Sponsors
aimnext
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 19 years or older and under 65 years at the time of providing written informed consent. 2) Individuals who meet the DSM-5 diagnostic criteria for panic disorder or have received one or more of the following ICD-10 diagnostic codes : F41.0: Panic disorder / Panic attack / Panic state F40.0: Agoraphobia / Agoraphobia without history of panic disorder / Panic disorder with agoraphobia 3) Individuals who meet one of the following criteria at screening : Patients with panic disorder without agoraphobia who have a score of =6 on the Korean version of the Panic Disorder Severity Scale–Self Report (PDSS-SR) Patients with panic disorder with agoraphobia who have a score of =8 on the Korean version of the PDSS-SR 4) Individuals with no difficulty reading or writing in Korean. 5) Individuals who can use smartphone applications without difficulty. 6) Individuals who agree to use medically acceptable contraception* until the end of the clinical trial. *Medically acceptable methods of contraception include: being infertile (e.g., hysterectomy, vasectomy), use of intrauterine devices (IUDs), or simultaneous use of barrier methods (male or female condoms) in combination with spermicides. 7) Individuals who have received and understood sufficient explanation about the clinical trial, voluntarily decided to participate, and provided written informed consent agreeing to comply with all study requirements.
Exclusion criteria
Exclusion criteria: 1) Individuals who, at the time of providing written informed consent, exhibit any of the following psychiatric symptoms : Schizophrenia spectrum disorders, Manic episodes, Major depressive episodes, Substance use disorders 2) Individuals who have ever been diagnosed with any of the following psychiatric disorders during their lifetime : Schizophrenia spectrum disorders, Substance use disorders 3) Individuals who, at the time of providing written informed consent, have uncontrolled or hospitalization-requiring systemic medical conditions. 4) Individuals who have attempted suicide within the past 3 months from the date of informed consent or are assessed as being at high risk of suicide by a psychiatrist. 5) Individuals who, within the past 3 months from the date of informed consent, have newly initiated or are currently undergoing any cognitive behavioral therapy (CBT)—including CBT for panic disorder or other conditions. 6) Individuals with visual or hearing impairments, or cognitive impairments (e.g., intellectual disability, dementia). 7) Pregnant or breastfeeding women. 8) Individuals who, at the time of screening, have had changes in the type or dosage of medications (including prescription drugs and medications regularly prescribed for panic disorder) within the past 4 weeks. ? Individuals whose medication type and dosage have remained stable for at least 4 weeks are not excluded. Thus, patients who are on stable psychotropic medication for =4 weeks may participate in the clinical trial. However, pro re nata (PRN) prescriptions may be allowed, even if there have been changes in medication type, dosage, or frequency within the past 4 weeks. 9) Individuals who are otherwise deemed inappropriate for participation in this clinical trial at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Panic Disorder Severity Scale - Self Report (PDSS-SR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Panic Disorder Severity Scale (PDSS);Generalized Anxiety Disorder-7 (GAD-7);Patient Health Questionnaire-9 (PHQ-9);Global Impression – Severity (CGI-S);Global Impression – Improvement (CGI-I);Adverse Event / Serious Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactSeulki Lee
Korea University Anam Hospital
Outcome results
None listed