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Trial · NCT07892885

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

NCT07892885, Not applicable, Not yet recruiting, AIMNEXT

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder. Trials, record NCT07892885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892885

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
NCT number
NCT07892885
Status
Not yet recruiting
Phases
Not applicable
Enrollment
120 participants, estimated
Lead sponsor
AIMNEXT
Conditions
Panic Disorder, Agoraphobia
Interventions
Meltz, Sham Application
First posted
2026-10-23
Last updated
2026-10-23

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Panic Disorder Severity Scale-Self Report (PDSS-SR) Total Score at End of TreatmentBaseline and Week 10
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.
SecondaryProportion of Participants with a ≥40% Reduction in PDSS-SR Total ScoreBaseline and Week 10The 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.
SecondaryProportion of Participants with a PDSS-SR Total Score ≤5Week 10Proportion 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.
SecondaryChange in Panic Disorder Severity Scale (PDSS) Total ScoreBaseline and Week 10
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.
SecondaryChange in State-Trait Anxiety Inventory (STAI) State Anxiety ScoreBaseline and Week 10
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.
SecondaryChange in State-Trait Anxiety Inventory (STAI) Trait Anxiety ScoreBaseline and Week 10
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.
SecondaryChange in Agoraphobic Cognitions Questionnaire (ACQ) ScoreBaseline and Week 10
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.
SecondaryChange in Albany Panic and Phobia Questionnaire (APPQ) ScoreBaseline and Week 10
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.
SecondaryChange in Generalized Anxiety Disorder-7 (GAD-7) Total ScoreBaseline and Week 10
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.
SecondaryChange in Patient Health Questionnaire-9 (PHQ-9) Total ScoreBaseline and Week 10
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers26

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
2691207BACKGROUNDPubMed
6520279BACKGROUNDPubMed
9356566BACKGROUNDPubMed
10815116BACKGROUNDPubMed
11556941BACKGROUNDPubMed
11772690BACKGROUNDPubMed
12112724BACKGROUNDPubMed
16005982BACKGROUNDPubMed
16717171BACKGROUNDPubMed
19006198BACKGROUNDPubMed

1 to 10 of 26

See all 26 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07892885

GET https://conductscience.org/api/trials/v1/NCT07892885/papers?page=2