Panic DisorderNCT07247955
Guided and Traditional Cognitive Behavioral Therapy Protocol for Resistant Panic
A study testing The group intervention used the sessions described in traditional form and The group intervention used the sessions described in a self-guided format using an application in people with Panic Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
Self-guided therapy for anxiety disorders has focused on various cognitive-behavioral treatments mediated by technologies such as web applications. This study aims to compare two groups of patients with panic disorder undergoing two clinical psychological treatment models: one traditional cognitive behavioral therapy… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder
- What is being tested?
- The group intervention used the sessions described in traditional form and The group intervention used the sessions described in a self-guided format using an application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Apr 2023to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing IPUB screening through the panic and respiratory laboratory outpatient clinic.
- Diagnosis of panic disorder confirmed.
- Age between 18 and 60 years.
- Under psychiatric follow-up by a university psychiatrist and taking medication.
- Provide written informed consent to participate and have data stored.
Who cannot join
- Patients without a diagnosis of panic disorder.
- Age under 18 or over 60 years.
- Not undergoing psychiatric follow-up.
- Presence of other psychiatric or medical diagnoses.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio de JAneiro
Rio de Janeiro, Rio de Janeiro, Tel. (+55 21) 25216147
About this study
Official title: Effectiveness of the Guided and Traditional Cognitive Behavioral Therapy Protocol in a Patient With Treatment-resistant Panic Disorder
Self-guided therapy for anxiety disorders has focused on various cognitive-behavioral treatments mediated by technologies such as web applications. This study aims to compare two groups of patients with panic disorder undergoing two clinical psychological treatment models: one traditional cognitive behavioral therapy (CBT), and the other self-guided CBT using a digital application.
An application was developed in which both treatment models follow the same eight-session CBT manual. Patients are evaluated using psychological assessments at the first and eighth sessions.
The study includes 46 patients divided into two groups of 23 participants each. Both groups undergo individual assessments at the beginning and end of the treatment protocol.
Read the detailed description
As such, an application was developed whereby the two models follow the same treatment manual of eight sessions, with the patients being evaluated using psychological tests at the first and eighth sessions.
Methods: A total of 46 patients were separated into two groups of 23 patients, one in each format, with the patients in both groups being individually evaluated at their first and eighth sessions.
- Conditions
- Panic Disorder
- Being tested
- The group intervention used the sessions described in traditional form, The group intervention used the sessions described in a self-guided format using an application
- Keywords
- Panic disorder, Cognitive behavioral therapy, Application
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group intervention used the sessions described in traditional formBehavioural
Model of the sessions:
- Session 1 - General information for the Client
- Session 2 - Breaking the panic cycle
- Session 3 - Increasing the range of cognitive management skills
- Session 4 - Improving corporal management skills
- Session 5 - Strengthening self-efficacy
- Session 6 - Stimulating life reorientation
- Session 7 - Promoting existential management
- Session 8 - Revising and evaluating the treatment
The group intervention used the sessions described in a self-guided format using an applicationBehavioural
Model of the sessions:
- Session 1 - General information for the Client
- Session 2 - Breaking the panic cycle
- Session 3 - Increasing the range of cognitive management skills
- Session 4 - Improving corporal management skills
- Session 5 - Strengthening self-efficacy
- Session 6 - Stimulating life reorientation
- Session 7 - Promoting existential management
- Session 8 - Revising and evaluating the treatment
| Study group | Role | What they receive |
|---|---|---|
| Group of 23 patients undergoing traditional cognitive behavioral therapy | Experimental | Twenty-three patients were selected for group. The group consisted of patients with panic disorder and breathing difficulties in a traditional cognitive behavioral therapy format, 8-session treatment protocol. Receives: Behavioral: The group intervention used the sessions described in traditional form |
| Group of 23 patients undergoing self-guided cognitive behavioral therapy using an app | Experimental | Twenty-three patients were selected for group. The group consisted of patients with panic disorder and breathing difficulties in a self-guided cognitive behavioral therapy format, using the 8-session treatment protocol. Receives: Behavioral: The group intervention used the sessions described in a self-guided format using an application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy criteria
Primary Outcome Measure 1 Title: Beck Anxiety Inventory (BAI) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BAI is a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Total scores range from 0 to 63; higher scores indicate greater anxiety. Administered to all participants in both groups. Results will be reported separately for each time point.
Unit of Measure: Points on a scale (0-63) Primary Outcome Measure 2 Title: Beck Depression Inventory (BDI) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BDI is a 21-item self-report inventory assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater severity of depression. Applied to all participants in both groups, with separate reporting for each assessment.
Unit of Measure: Points on a scale (0-63)
Measured: Baseline (Week 1) and Post-intervention (Week 8)
Secondary outcomes (1)
Efficacy criteria
Outcome Measure 3 Title: Mindful Attention Awareness Scale (MAAS) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The MAAS is a 15-item scale measuring mindfulness in daily life. Scores range from 15 to 90; higher scores reflect greater mindfulness. Administered to all participants. Scores will be reported separately at each time point.
Unit of Measure: Points on a scale (15-90) Outcome Measure 4 Title: Brief Resilient Coping Scale (BRCS) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BRCS is a 4-item scale assessing the tendency to cope with stress in a resilient manner. Scores range from 4 to 20; higher scores indicate more adaptive coping. Administered to both groups. Each time point reported separately.
Unit of Measure: Points on a scale (4-20)
Measured: Baseline (Week 1) and Post-intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start5 Apr 2023
- Primary completion15 Oct 2024
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- As a pilot study comparing two groups of patients with PD in different forms of care, the data from 23 patients with panic disorder undergoing traditional CBT and 23 patients with panic disorder doing self-guided therapy through an application were collected. The groups were randomized, they had no comorbidities, all patients were undergoing psychiatric follow-up.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luisa Pelucio Ribeiro Barbosa, Universidade Federal do Rio de Janeiro
- Investigators
- Luisa Pelucio, Master, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247955
- Sponsor's protocol ID
- UFRJ-2025-001
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gal E, Stefan S, Cristea IA. The efficacy of mindfulness meditation apps in enhancing users' well-being and mental health related outcomes: a meta-analysis of randomized controlled trials. J Affect Disord. 2021 Jan 15;279:131-142. doi: 10.1016/j.jad.2020.09.134. Epub 2020 Oct 7.
PubMed 33049431Yogeswaran V, El Morr C. Effectiveness of online mindfulness interventions on medical students' mental health: a systematic review. BMC Public Health. 2021 Dec 18;21(1):2293. doi: 10.1186/s12889-021-12341-z.
PubMed 34920715Linardon J. Can Acceptance, Mindfulness, and Self-Compassion Be Learned by Smartphone Apps? A Systematic and Meta-Analytic Review of Randomized Controlled Trials. Behav Ther. 2020 Jul;51(4):646-658. doi: 10.1016/j.beth.2019.10.002. Epub 2019 Nov 26.
PubMed 32586436Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2012 Nov 14;11:CD006611. doi: 10.1002/14651858.CD006611.pub3.
PubMed 23152238Bakker D, Kazantzis N, Rickwood D, Rickard N. Mental Health Smartphone Apps: Review and Evidence-Based Recommendations for Future Developments. JMIR Ment Health. 2016 Mar 1;3(1):e7. doi: 10.2196/mental.4984.
PubMed 26932350Loucas CE, Fairburn CG, Whittington C, Pennant ME, Stockton S, Kendall T. E-therapy in the treatment and prevention of eating disorders: A systematic review and meta-analysis. Behav Res Ther. 2014 Dec;63:122-31. doi: 10.1016/j.brat.2014.09.011. Epub 2014 Oct 5.
PubMed 25461787Schueller SM, Torous J. Scaling evidence-based treatments through digital mental health. Am Psychol. 2020 Nov;75(8):1093-1104. doi: 10.1037/amp0000654.
PubMed 33252947Wu J, Ma Y, Zuo Y, Zheng K, Zhou Z, Qin Y, Ren Z. Effects of Mindfulness Exercise Guided by a Smartphone App on Negative Emotions and Stress in Non-Clinical Populations: A Systematic Review and Meta-Analysis. Front Public Health. 2022 Jan 25;9:773296. doi: 10.3389/fpubh.2021.773296. eCollection 2021.
PubMed 35155341Rathbone AL, Clarry L, Prescott J. Assessing the Efficacy of Mobile Health Apps Using the Basic Principles of Cognitive Behavioral Therapy: Systematic Review. J Med Internet Res. 2017 Nov 28;19(11):e399. doi: 10.2196/jmir.8598.
PubMed 29187342Hansen WB, Scheier LM. Specialized Smartphone Intervention Apps: Review of 2014 to 2018 NIH Funded Grants. JMIR Mhealth Uhealth. 2019 Jul 29;7(7):e14655. doi: 10.2196/14655.
PubMed 31359866Hwang WJ, Ha JS, Kim MJ. Research Trends on Mobile Mental Health Application for General Population: A Scoping Review. Int J Environ Res Public Health. 2021 Mar 2;18(5):2459. doi: 10.3390/ijerph18052459.
PubMed 33801537Firth J, Torous J, Carney R, Newby J, Cosco TD, Christensen H, Sarris J. Digital Technologies in the Treatment of Anxiety: Recent Innovations and Future Directions. Curr Psychiatry Rep. 2018 May 19;20(6):44. doi: 10.1007/s11920-018-0910-2.
PubMed 29779065Wright JH, Mishkind M, Eells TD, Chan SR. Computer-Assisted Cognitive-Behavior Therapy and Mobile Apps for Depression and Anxiety. Curr Psychiatry Rep. 2019 Jun 27;21(7):62. doi: 10.1007/s11920-019-1031-2.
PubMed 31250242Khademian F, Aslani A, Bastani P. The effects of mobile apps on stress, anxiety, and depression: overview of systematic reviews. Int J Technol Assess Health Care. 2020 Dec 14;37:e4. doi: 10.1017/S0266462320002093.
PubMed 33314997Ito LM, Noshirvani H, Basoglu M, Marks IM. Does exposure to internal cues enhance exposure to external cues in agoraphobia with panic? A pilot controlled study of self-exposure. Psychother Psychosom. 1996;65(1):24-28. doi: 10.1159/000289027.
PubMed 8838693
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Guided and Traditional Cognitive Behavioral Therapy Protocol in a Patient With Treatment-resistant Panic Disorder
- ClinicalTrials.gov ID
- NCT07247955
- Acronym / sponsor ID
- UFRJ-2025-001
- Conditions
- Panic Disorder
- Keywords
- Panic disorder, Cognitive behavioral therapy, Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Self-guided therapy for anxiety disorders has focused on various cognitive-behavioral treatments mediated by technologies such as web applications. This study aims to compare two groups of patients with panic disorder undergoing two clinical psychological treatment models: one traditional cognitive behavioral therapy (CBT), and the other self-guided CBT using a digital application.
An application was developed in which both treatment models follow the same eight-session CBT manual. Patients are evaluated using psychological assessments at the first and eighth sessions.
The study includes 46 patients divided into two groups of 23 participants each. Both groups undergo individual assessments at the beginning and end of the treatment protocol.
Detailed description
As such, an application was developed whereby the two models follow the same treatment manual of eight sessions, with the patients being evaluated using psychological tests at the first and eighth sessions.
Methods: A total of 46 patients were separated into two groups of 23 patients, one in each format, with the patients in both groups being individually evaluated at their first and eighth sessions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- As a pilot study comparing two groups of patients with PD in different forms of care, the data from 23 patients with panic disorder undergoing traditional CBT and 23 patients with panic disorder doing self-guided therapy through an application were collected. The groups were randomized, they had no comorbidities, all patients were undergoing psychiatric follow-up.
| Arm | Type | Receives |
|---|---|---|
| Group of 23 patients undergoing traditional cognitive behavioral therapy | Experimental | Behavioral: The group intervention used the sessions described in traditional formTwenty-three patients were selected for group. The group consisted of patients with panic disorder and breathing difficulties in a traditional cognitive behavioral therapy format, 8-session treatment protocol. |
| Group of 23 patients undergoing self-guided cognitive behavioral therapy using an app | Experimental | Behavioral: The group intervention used the sessions described in a self-guided format using an applicationTwenty-three patients were selected for group. The group consisted of patients with panic disorder and breathing difficulties in a self-guided cognitive behavioral therapy format, using the 8-session treatment protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients undergoing IPUB screening through the panic and respiratory laboratory outpatient clinic.
- Diagnosis of panic disorder confirmed.
- Age between 18 and 60 years.
- Under psychiatric follow-up by a university psychiatrist and taking medication.
- Provide written informed consent to participate and have data stored.
Key exclusion criteria (4 listed)
- Patients without a diagnosis of panic disorder.
- Age under 18 or over 60 years.
- Not undergoing psychiatric follow-up.
- Presence of other psychiatric or medical diagnoses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The group intervention used the sessions described in traditional formModel of the sessions: * Session 1 - General information for the Client * Session 2 - Breaking the panic cycle * Session 3 - Increasing the range of cognitive management skills * Session 4 - Improving corporal management skills * Session 5 - Strengthening self-efficacy * Session 6 - Stimulating life reorientation * Session 7 - Promoting existential management * Session 8 - Revising and evaluating the treatment | Behavioural | Group of 23 patients undergoing traditional cognitive behavioral therapy |
| The group intervention used the sessions described in a self-guided format using an applicationModel of the sessions: * Session 1 - General information for the Client * Session 2 - Breaking the panic cycle * Session 3 - Increasing the range of cognitive management skills * Session 4 - Improving corporal management skills * Session 5 - Strengthening self-efficacy * Session 6 - Stimulating life reorientation * Session 7 - Promoting existential management * Session 8 - Revising and evaluating the treatment | Behavioural | Group of 23 patients undergoing self-guided cognitive behavioral therapy using an app |
Primary outcome
Efficacy criteria
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Primary Outcome Measure 1 Title: Beck Anxiety Inventory (BAI) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BAI is a 21-item self-report questionnaire that measures the severity of anxiety symptoms. Total scores range from 0 to 63; higher scores indicate greater anxiety. Administered to all participants in both groups. Results will be reported separately for each time point. Unit of Measure: Points on a scale (0-63) Primary Outcome Measure 2 Title: Beck Depression Inventory (BDI) total score Time Frame: Baseline (Week 1) and Post-intervention (Week 8) Description: The BDI is a 21-item self-report inventory assessing depressive symptoms. Scores range from 0 to 63, with higher scores indicating greater severity of depression. Applied to all participants in both groups, with separate reporting for each assessment. Unit of Measure: Points on a scale (0-63)
1 secondary outcome
Efficacy criteria
Time frame: Baseline (Week 1) and Post-intervention (Week 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Results publication: PubMed 33049431Gal E, Stefan S, Cristea IA. The efficacy of mindfulness meditation apps in enhancing users' well-being and mental health related outcomes: a meta-analysis of randomized controlled trials. J Affect Disord. 2021 Jan 15;279:131-142. doi: 10.1016/j.jad.2020.09.134. Epub 2020 Oct 7.
- Results publication: PubMed 34920715Yogeswaran V, El Morr C. Effectiveness of online mindfulness interventions on medical students' mental health: a systematic review. BMC Public Health. 2021 Dec 18;21(1):2293. doi: 10.1186/s12889-021-12341-z.
- Results publication: PubMed 32586436Linardon J. Can Acceptance, Mindfulness, and Self-Compassion Be Learned by Smartphone Apps? A Systematic and Meta-Analytic Review of Randomized Controlled Trials. Behav Ther. 2020 Jul;51(4):646-658. doi: 10.1016/j.beth.2019.10.002. Epub 2019 Nov 26.
- Results publication: PubMed 23152238Whittaker R, McRobbie H, Bullen C, Borland R, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2012 Nov 14;11:CD006611. doi: 10.1002/14651858.CD006611.pub3.
- Results publication: PubMed 26932350Bakker D, Kazantzis N, Rickwood D, Rickard N. Mental Health Smartphone Apps: Review and Evidence-Based Recommendations for Future Developments. JMIR Ment Health. 2016 Mar 1;3(1):e7. doi: 10.2196/mental.4984.
- Results publication: PubMed 25461787Loucas CE, Fairburn CG, Whittington C, Pennant ME, Stockton S, Kendall T. E-therapy in the treatment and prevention of eating disorders: A systematic review and meta-analysis. Behav Res Ther. 2014 Dec;63:122-31. doi: 10.1016/j.brat.2014.09.011. Epub 2014 Oct 5.
- Results publication: PubMed 33252947Schueller SM, Torous J. Scaling evidence-based treatments through digital mental health. Am Psychol. 2020 Nov;75(8):1093-1104. doi: 10.1037/amp0000654.
- Results publication: PubMed 35155341Wu J, Ma Y, Zuo Y, Zheng K, Zhou Z, Qin Y, Ren Z. Effects of Mindfulness Exercise Guided by a Smartphone App on Negative Emotions and Stress in Non-Clinical Populations: A Systematic Review and Meta-Analysis. Front Public Health. 2022 Jan 25;9:773296. doi: 10.3389/fpubh.2021.773296. eCollection 2021.
- Results publication: PubMed 29187342Rathbone AL, Clarry L, Prescott J. Assessing the Efficacy of Mobile Health Apps Using the Basic Principles of Cognitive Behavioral Therapy: Systematic Review. J Med Internet Res. 2017 Nov 28;19(11):e399. doi: 10.2196/jmir.8598.
- Results publication: PubMed 31359866Hansen WB, Scheier LM. Specialized Smartphone Intervention Apps: Review of 2014 to 2018 NIH Funded Grants. JMIR Mhealth Uhealth. 2019 Jul 29;7(7):e14655. doi: 10.2196/14655.
- Results publication: PubMed 33801537Hwang WJ, Ha JS, Kim MJ. Research Trends on Mobile Mental Health Application for General Population: A Scoping Review. Int J Environ Res Public Health. 2021 Mar 2;18(5):2459. doi: 10.3390/ijerph18052459.
- Results publication: PubMed 29779065Firth J, Torous J, Carney R, Newby J, Cosco TD, Christensen H, Sarris J. Digital Technologies in the Treatment of Anxiety: Recent Innovations and Future Directions. Curr Psychiatry Rep. 2018 May 19;20(6):44. doi: 10.1007/s11920-018-0910-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luisa Pelucio, Master principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group intervention used the sessions described in traditional form and The group intervention used the sessions described in a self-guided format using an application in people with Panic Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy criteria (time frame: Baseline (Week 1) and Post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07247955, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.