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A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
Sponsor: AIMNEXT
Summary
i. This randomized clinical trial will evaluate the efficacy and safety of Meltz, a digital therapeutic device that provides cognitive behavioral therapy (CBT) for adults with panic disorder. ii. Participants will be randomly assigned to use either Meltz or a sham application. Meltz provides personalized CBT for panic disorder through a smartphone application, while the sham application is similar in appearance and manner of use but does not provide the core therapeutic functions of Meltz. The treatment program is completed within 8 to 10 weeks depending on each participant's treatment progress. iii. This study will evaluate whether Meltz is more effective than the sham application in improving panic symptoms. The primary outcome is the change from baseline to Week 10 in the total score of the Panic Disorder Severity Scale-Self Report (PDSS-SR), a questionnaire used to assess the severity of panic disorder symptoms. The safety of Meltz will also be evaluated based on adverse events reported during the clinical trial.
Official title: A Multicenter, Prospective, Randomized, Sham-controlled, Single-blind, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy, Assessed by the Panic Disorder Severity Scale-Self Report, and Safety of the 'Meltz' Digital Therapeutics for Improving Panic Symptoms in Patients Diagnosed With Panic Disorder
Key Details
Gender
All
Age Range
19 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-10
Completion Date
2027-03
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Meltz
Meltz is a software-based digital therapeutic device that provides personalized cognitive behavioral therapy for panic disorder (CBT-P). The program includes psychoeducation, self-monitoring, cognitive restructuring, exposure to fear cues, modification of anxiety-maintaining behaviors, relaxation training, and relapse prevention. Meltz also provides educational content, real-time feedback, behavioral interventions, and push notifications to support treatment adherence.
Sham Application
The sham application is similar to Meltz in appearance and manner of use but does not provide the core therapeutic functions of Meltz. It does not provide CBT-P treatment content, personalized treatment recommendations based on treatment progress, real-life exposure training, or prediction checklist completion. It provides only management functions, including psychological questionnaires and mood and panic records.