An interventional study of Meltz and Sham Application in Panic Disorder and Agoraphobia, sponsored by AIMNEXT. Not yet recruiting. Open to participants aged 19 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by AIMNEXT · Not applicable, Interventional, and Treatment
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.
256 studies on the registry are indexed under Panic Disorder; 35 are open to participants now.
This study's planned enrollment of 120 is above the median of 78 across 201 interventional studies indexed under Panic Disorder.
Browse Panic Disorder studies →This is the only study on the registry with AIMNEXT as lead sponsor.
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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
Exclusion Criteria:
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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 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.
However, participants meeting any of the following conditions may participate in the clinical trial:
4) 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.
5) 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.
6) Non-psychiatric medications:
8. Participants who, in the investigator's judgment, are considered unsuitable for participation in this clinical trial.
Participants assigned to the Meltz group use the Meltz digital therapeutic device. The program provides personalized cognitive behavioral therapy for panic disorder (CBT-P) through a smartphone application and is completed within 8 to 10 weeks depending on each participant's treatment progress.
Device: Meltz
An interventional study must have at least one arm with Arm Type other than Placebo Comparator or Sham Comparator.
Device: Sham Application
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.
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.
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Treatment
The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms.
Time frame: Baseline and Week 10
Proportion of Participants with a ≥40% Reduction in PDSS-SR Total Score
The proportion of participants with a ≥40% reduction in the PDSS-SR total score from baseline at 10 weeks after application of the investigational or comparator device.
Time frame: Baseline and Week 10
Proportion of Participants with a PDSS-SR Total Score ≤5
Proportion of Participants with a PDSS-SR Total Score ≤5 The proportion of participants with a PDSS-SR total score ≤5 at 10 weeks after application of the investigational or comparator device.
Time frame: Week 10
Change in Panic Disorder Severity Scale (PDSS) Total Score
The PDSS consists of the same 7 items as the PDSS-SR but is administered by a clinician through a structured interview. Each item is rated from 0 to 4, yielding a total score ranging from 0 to 28. Lower total scores indicate improvement or alleviation of panic symptoms. The criteria for interpreting the total score are the same as those for the PDSS-SR.
Time frame: Baseline and Week 10
Change in State-Trait Anxiety Inventory (STAI) State Anxiety Score
The State-Trait Anxiety Inventory (STAI) assesses anxiety in two dimensions: anxiety as a temporary emotional state (state anxiety, STAI-1) and anxiety as a persistent personality trait (trait anxiety, STAI-2). STAI-1 consists of 20 items, with a total score ranging from 20 to 80. Lower scores indicate improvement or alleviation of anxiety. Positively worded items (e.g., "I feel calm") are reverse-scored.
Time frame: Baseline and Week 10
Change in State-Trait Anxiety Inventory (STAI) Trait Anxiety Score
The State-Trait Anxiety Inventory (STAI) assesses anxiety in two dimensions: anxiety as a temporary emotional state (state anxiety, STAI-1) and anxiety as a persistent personality trait (trait anxiety, STAI-2). STAI-2 consists of 20 items, with a total score ranging from 20 to 80. Lower scores indicate improvement or alleviation of anxiety. Positively worded items are reverse-scored.
Time frame: Baseline and Week 10
Change in Agoraphobic Cognitions Questionnaire (ACQ) Score
The Agoraphobic Cognitions Questionnaire (ACQ) is a 14-item measure that assesses the frequency of catastrophic thoughts that spontaneously occur when a person feels anxious or tense. Each item is rated from 1 to 5 according to how often the thought occurs during an anxious state. Lower scores indicate a reduction in the frequency of catastrophic cognitions and improvement in cognitive symptoms.
Time frame: Baseline and Week 10
Change in Albany Panic and Phobia Questionnaire (APPQ) Score
The Albany Panic and Phobia Questionnaire (APPQ) is a 27-item measure that assesses fear and avoidance related to panic- and phobia-related situations. Each item is rated from 0 to 8 according to the current level of fear and avoidance associated with the situation. The APPQ consists of three subscales: agoraphobia (14 items), social phobia (8 items), and interoceptive fear (5 items). Each subscale score is calculated by summing the corresponding item scores. Lower total and subscale scores indicate reduced fear and avoidance behavior and clinically meaningful improvement.
Time frame: Baseline and Week 10
Change in Generalized Anxiety Disorder-7 (GAD-7) Total Score
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure that assesses the severity of generalized anxiety disorder and general anxiety symptoms. Each item is rated from 0 to 3 based on experiences during the previous 2 weeks, yielding a total score ranging from 0 to 21.
Time frame: Baseline and Week 10
Change in Patient Health Questionnaire-9 (PHQ-9) Total Score
The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure of the severity of depressive symptoms and assesses the nine symptoms of a depressive episode based on DSM diagnostic criteria. Each item is rated from 0 to 3 based on experiences during the previous 2 weeks, yielding a total score ranging from 0 to 27.
Time frame: Baseline and Week 10
Change in EuroQol 5-Dimension Score
The EuroQol 5-Dimension (EQ-5D) is a self-report measure of health-related quality of life (HRQoL) consisting of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed on five levels: no problems, slight problems, moderate problems, severe problems, and extreme problems (levels 1-5).
Time frame: Baseline and Week 10
Change in Clinical Global Impression-Severity (CGI-S) Score
The Clinical Global Impression-Severity (CGI-S) is a clinician-rated scale that assesses the severity of illness. Scores are rated as follows: 0 = Not assessed; 1 = Normal, not at all ill; 2 = Borderline mentally ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; and 7 = Among the most extremely ill patients.
Time frame: Baseline and Week 10
Clinical Global Impression-Improvement (CGI-I) Score
The Clinical Global Impression-Improvement (CGI-I) is a clinician-rated scale that assesses overall change relative to baseline. No separate baseline CGI-I assessment is performed, and the CGI-I score is assessed at Week 10. Scores are rated as follows: 0 = Not assessed; 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; and 7 = Very much worse.
Time frame: Week 10
Change in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of Study
The Panic Disorder Severity Scale-Self Report (PDSS-SR) is a 7-item self-report measure used by participants to assess the severity of panic disorder. Each item is rated from 0 to 4 based on experiences during the previous week, yielding a total score ranging from 0 to 28. Lower total scores indicate greater improvement or alleviation of panic symptoms.
Time frame: Baseline and Week 18
Overall Cumulative Treatment Adherence
Adherence data are continuously collected and reviewed throughout the treatment period, and overall cumulative treatment adherence is calculated at Visit 6 using data accumulated from Visit 2 through Visit 6. For participants in the Meltz group, adherence is based on the number of completed treatment stages out of 77 total assigned stages. For participants in the sham control group, adherence is based on the number of days on which at least one mood or panic diary entry is completed during the period from Visit 2 through Visit 6
Time frame: From treatment initiation (Visit 2) through Week 10 (Visit 6)
No study locations are listed for this record.
Plan to share: Yes — all IPD that underlie results in a publication
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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