Anxiety DisordersKOMMANCT05942391
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
A study testing Cognitive behavioral therapy (CBT) in people with Anxiety Disorders and Obsessive-Compulsive Disorder, run by Amsterdam UMC, location VUmc at 6 sites in Netherlands.
Trial summary
The goal of this clinical trial is to compare brief-intensive cognitive-behaviour therapy (CBT) with regular weekly CBT in people with anxiety-related disorders. The main question to answer is: will brief-intensive CBT improve functioning (work, family, social) more and faster than does regular weekly CBT?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder
- What is being tested?
- Cognitive behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 6 sitesNetherlands
- Study dates
- 26 Apr 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Reaching out for mental health care for one of the following disorders:
- panic disorder, agoraphobia, generalised anxiety disorder, social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, health anxiety disorder.
Who cannot join
- Is in need of emergency mental health care
- Has insufficient language skills in Dutch
- Has evident cognitive limitations
- Has had changes in the use of medication during the last 3 months.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
GGZ inGeest, polikliniek Angst & Dwang, locatie Amstelmere
Amstelveen
GGZ inGeest, polikliniek Angst & Dwang, locatie De Nieuwe Valerius
Amsterdam
GGZ inGeest, polikliniek Angst & Dwang, locatie Zuiderpoort
Haarlem
GGZ Centraal, Algemeen Specialistische Polikliniek
Hilversum
GGZ inGeest, polikliniek Angst & Dwang, locatie Spaarnepoort
Hoofddorp
Altrecht Academisch Angstcentrum
Utrecht
About this study
Official title: Fast Recovery From Anxiety-related Disorders: Brief-intensive CBT Versus Once-weekly CBT
The goal of this clinical trial is to compare brief-intensive cognitive-behaviour therapy (CBT) with regular weekly CBT in people with anxiety-related disorders.
The main question to answer is: will brief-intensive CBT improve functioning (work, family, social) more and faster than does regular weekly CBT?
Participants will be asked to follow CBT treatment (20 sessions of 45 minutes in both conditions), and participate in 7 measurements with a total duration of 5 hours over 1 year.
Researchers will compare:
- Brief-intensive CBT: 16 sessions in 2 weeks + 4 follow-up sessions within 3 months
- Regular CBT with 20 weekly sessions in 6 months
Read the detailed description
Rationale: Anxiety-related disorders (i.e., obsessive compulsive, health anxiety and trauma disorders) affect about 10% of the adults. Though clinically heterogeneous, transdiagnostic aspects are expected disasters, anxiety and avoidance. Profound impairments include work and family functioning. Many enter a vicious circle with comorbidity and further decline in quality of life. Hence, the impact on functioning is tremendous, with anxiety-related disorders rating highest on disability rankings in the age 15-64 years. Cognitive behavioral therapy (CBT) is the preferred and often only psychotherapy for these disorders. Because guidelines are based on weekly sessions, recovery takes half a year at least. Based on initial research findings, we expect faster recovery by providing CBT in a brief-intensive format (BI-CBT), with clear benefts for patients, families and society. Some institutions already provide BI-CBT. However, evidence to justify this or to further implement BI-CBT is insufficient.
Study design: a parallel-group randomised controlled multicenter intervention study.
Study population: Adults aged 18-65 yr old with an anxiety-related disorder (panic, agrophobia, social anxiety, generalised anxiety obsessions/compulsions, health anxiety and post-traumatic stress)
Intervention (if applicable): One group receives BI-CBT (16 sessions in 2 weeks + 4 follow up sessions) and the other group receives 20 weekly CBT sessions. Treatment in both conditions can be personalised by a focus on work or family functioning.
Main study parameters/endpoints: The main study parameter is the 'area under the curve' for 6-month health and disability. Also, 1 year efficacy (both on functioning and symptom-level), cost-effectiveness, and feasibility will be assessed. Potential predictors of treatment preference, efficacy and drop-out will be explored.
All patients are expected to follow CBT (20 sessions of 45min) and participate in 7 measurements over 1 year.
The general measurements are online questionnaires and interviews by telephone, asking about someones functioning, quality of life and symptoms of anxiety or depression, how one copes with these and what one expects of the therapy.
The acronym KOMMA is based on the Dutch translation of 'to put a quick end to anxiety': Korte Metten Met Angst.
- Conditions
- Anxiety Disorders, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Hypochondriasis
- Being tested
- Cognitive behavioral therapy (CBT)
- Keywords
- agoraphobia, social anxiety disorder, generalized anxiety disorder, panic disorder, trauma, health anxiety, obsessive compulsive disorder, CBT
- Medical subject headings
- Anxiety Disorders, Obsessive-Compulsive Disorder, Stress Disorders, Post-Traumatic, Hypochondriasis, Agoraphobia, Phobia, Social, Generalized Anxiety Disorder, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT)Behavioural
Also called exposure therapy
The intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Brief-Intensive CBT | Experimental | 16 sessions in 2 weeks + 4 follow up sessions. The CBT consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks, + 4 sessions within 3 months. Receives: Behavioral: Cognitive behavioral therapy (CBT) |
| weekly CBT | Active comparator | 20 weekly CBT sessions within 5 to 6 months. The CBT consists of exposure therapy. Receives: Behavioral: Cognitive behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the health and disability Curve at 6 months
The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability.
Measured: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months
Secondary outcomes (17)
Area Under the health and disability Curve at 12 months
The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability.
Measured: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months
Change from baseline in severity of anxiety symptoms at post-treatment
Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 28-item Mobility Inventory, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses.
Measured: baseline and 3 or 6 months
Change from baseline in severity of anxiety symptoms at 3 months
Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 15-item Fear Questionnaire, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses.
Measured: baseline and 3 months
Change from baseline in severity of anxiety symptoms at 12 months
Severity of anxiety-related disorder, measured with the following disorder-specific severity questionnaires: the 24-item Liebowitz Social Anxiety Scale self-report version, the 7-item Panic Disorder Severity Scale self-report version, the 28-item Mobility Inventory, the 16-item Penn State Worry Questionnaire, the 10-item Yale-Brown Obsessive Compulsive Scale self-report version, the 20-item PTSD checklist for the DSM-5, or the 14-item Whitely Index. Higher scores indicate higher symptom severity. Z-scores will be calculated from individual scores for group-level analyses.
Measured: baseline and 12 months
Change from baseline in severity of depressive symptoms at post-treatment
Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity.
Measured: baseline and 3 or 6 months
Change from baseline in severity of depressive symptoms at 3 months
Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity.
Measured: baseline and 3 months
Change from baseline in severity of depressive symptoms at 12 months
Severity of depressive symptoms are measured with the 30-item Inventory for Depressive Symptomatology self-report questionnaire. Higher scores indicate higher symptom severity.
Measured: baseline and 12 months
Remission rates from anxiety-related disorder at post-treatment
Remission of diagnoses of anxiety-related disorders is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019).
Measured: 3 or 6 months
Remission rates from anxiety-related disorder at 12 months
Remission of diagnoses of anxiety-related disorders is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019).
Measured: 12 months
New-onset anxiety-related or depressive disorder post-treatment
The new onset of anxiety-related or depressive disorder between baseline and post-treatment is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019)
Measured: baseline, 3 or 6 months
New-onset anxiety-related or depressive disorder at 12 months
The new onset of anxiety-related or depressive disorder between baseline and post-treatment is assessed using the Mini International Neuropsychiatric Interview - Simplified for DSM-5, Dutch version 1.1 (Overbeek \& Schruers, 2019)
Measured: 12 months
Productivity costs over 12 months
Productivity losses are assessed using the iMTA Productivity Cost Questionnaire (iPCQ). The iPCQ is a 12-item self-report questionnaire including three modules measuring productivity losses of paid work due to 1) absenteeism and 2) presenteeism and productivity losses related to 3) unpaid work in the past 3 months.
Measured: 3months, 6months, 12 months
Medical costs over 12 months
Medical costs from a mental health care perspective are assessed using the iMTA Medical Cost Questionnaire (iMCQ). The iMCQ is a 23-item self-report questionnaire, which apart from some general questions include questions on medical consumption from different healthcare providers in the past 3 months.
Measured: 3months, 6months, 12 months
Change from baseline in health-related quality of life over 12 months
Quality of life is measured using the EQ-5D-5L. The EQ-5D-5L scores (reflecting the level of perceived problems on the dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are used to calculate utilities using the Dutch tariff. Quality Adjusted Life Years are calculated using linear interpolation between time points. Higher QALY scores indicate more improvement in quality of life.
Measured: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months
Drop-out rates at post-treatment
Percentage of patiënts who missed more than 25% of CBT sessions.
Measured: 3 or 6 months
Patient satisfaction at post-treatment
The 8-item Client Satisfaction Questionnaire (CSQ-8) measures overall satisfaction of the patient with health and human services. Each item on the CSQ-8 is scored from 1 (low satisfaction) to 4 (high satisfaction), possible total scores ranging 8-32.
Measured: 3 or 6 months
Negative effects of psychotherapy
The 21-item Inventory for the Assessment of Negative Effects of Psychotherapy (INEP) is a self-report instrument for assessing negative effects of psychotherapy from the patient's perspective. The negative effects cover 7 domains: Intrapersonal Change, Intimate Relationships, Stigmatization, Emotions, Workplace, Family and Friends, and Therapeutic Malpractice. The INEP items are answered using a 4-stage response format (0 = "disagree/not applicable"; 3 = "fully agree").
Measured: 3 or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start26 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a parallel-group randomised controlled intervention study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Responsible party
- Principal investigator, Adrie Seldenrijk, Amsterdam UMC, location VUmc
- Investigators
- Neeltje Batelaan, PhD, Study director, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942391
- Sponsor's protocol ID
- DR2022-00396
- Acronym
- KOMMA
- Status last verified
- May 2026
- First submitted
- 16 Jun 2023
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Recovery From Anxiety-related Disorders: Brief-intensive CBT Versus Once-weekly CBT
- ClinicalTrials.gov ID
- NCT05942391
- Acronym / sponsor ID
- KOMMA / DR2022-00396
- Conditions
- Anxiety Disorders, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Hypochondriasis
- Keywords
- agoraphobia, social anxiety disorder, generalized anxiety disorder, panic disorder, trauma, health anxiety, obsessive compulsive disorder, CBT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 12 Jul 2023 (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.
The goal of this clinical trial is to compare brief-intensive cognitive-behaviour therapy (CBT) with regular weekly CBT in people with anxiety-related disorders.
The main question to answer is: will brief-intensive CBT improve functioning (work, family, social) more and faster than does regular weekly CBT?
Participants will be asked to follow CBT treatment (20 sessions of 45 minutes in both conditions), and participate in 7 measurements with a total duration of 5 hours over 1 year.
Researchers will compare:
- Brief-intensive CBT: 16 sessions in 2 weeks + 4 follow-up sessions within 3 months
- Regular CBT with 20 weekly sessions in 6 months
Detailed description
Rationale: Anxiety-related disorders (i.e., obsessive compulsive, health anxiety and trauma disorders) affect about 10% of the adults. Though clinically heterogeneous, transdiagnostic aspects are expected disasters, anxiety and avoidance. Profound impairments include work and family functioning. Many enter a vicious circle with comorbidity and further decline in quality of life. Hence, the impact on functioning is tremendous, with anxiety-related disorders rating highest on disability rankings in the age 15-64 years. Cognitive behavioral therapy (CBT) is the preferred and often only psychotherapy for these disorders. Because guidelines are based on weekly sessions, recovery takes half a year at least. Based on initial research findings, we expect faster recovery by providing CBT in a brief-intensive format (BI-CBT), with clear benefts for patients, families and society. Some institutions already provide BI-CBT. However, evidence to justify this or to further implement BI-CBT is insufficient.
Study design: a parallel-group randomised controlled multicenter intervention study.
Study population: Adults aged 18-65 yr old with an anxiety-related disorder (panic, agrophobia, social anxiety, generalised anxiety obsessions/compulsions, health anxiety and post-traumatic stress)
Intervention (if applicable): One group receives BI-CBT (16 sessions in 2 weeks + 4 follow up sessions) and the other group receives 20 weekly CBT sessions. Treatment in both conditions can be personalised by a focus on work or family functioning.
Main study parameters/endpoints: The main study parameter is the 'area under the curve' for 6-month health and disability. Also, 1 year efficacy (both on functioning and symptom-level), cost-effectiveness, and feasibility will be assessed. Potential predictors of treatment preference, efficacy and drop-out will be explored.
All patients are expected to follow CBT (20 sessions of 45min) and participate in 7 measurements over 1 year.
The general measurements are online questionnaires and interviews by telephone, asking about someones functioning, quality of life and symptoms of anxiety or depression, how one copes with these and what one expects of the therapy.
The acronym KOMMA is based on the Dutch translation of 'to put a quick end to anxiety': Korte Metten Met Angst.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a parallel-group randomised controlled intervention study
| Arm | Type | Receives |
|---|---|---|
| Brief-Intensive CBT | Experimental | Behavioral: Cognitive behavioral therapy (CBT)16 sessions in 2 weeks + 4 follow up sessions. The CBT consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks, + 4 sessions within 3 months. |
| weekly CBT | Active comparator | Behavioral: Cognitive behavioral therapy (CBT)20 weekly CBT sessions within 5 to 6 months. The CBT consists of exposure therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older;
- panic disorder, agoraphobia, generalised anxiety disorder, social anxiety disorder, posttraumatic stress disorder, obsessive-compulsive disorder, health anxiety disorder.
Key exclusion criteria (4 listed)
- Is in need of emergency mental health care
- Has insufficient language skills in Dutch
- Has evident cognitive limitations
- Has had changes in the use of medication during the last 3 months.
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 |
|---|---|---|
| Cognitive behavioral therapy (CBT)Also: exposure therapyThe intervention is brief-intensive, guided exposure therapy and consists of 16 sessions exposure therapy, spread over 4 half-days in 2 weeks plus 4 follow-up sessions within 3 months. | Behavioural | Brief-Intensive CBT, weekly CBT |
Primary outcome
Area Under the health and disability Curve at 6 months
Time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months
The 'area under the curve' for health and disability is based on the 36-item self-report World Health Organisation Disability Assessment Schedule (WHODAS 2.0). The WHODAS 2.0 captures the level of functioning in six domains of life: Cognition, Mobility, Self-care, Getting along, Life activities, Participation. Possible total scores of the items across all domains range 0 - 100. Lower scores indicate less disability.
17 secondary outcomes
Area Under the health and disability Curve at 12 months
Time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months
Change from baseline in severity of anxiety symptoms at post-treatment
Time frame: baseline and 3 or 6 months
Change from baseline in severity of anxiety symptoms at 3 months
Time frame: baseline and 3 months
Change from baseline in severity of anxiety symptoms at 12 months
Time frame: baseline and 12 months
Change from baseline in severity of depressive symptoms at post-treatment
Time frame: baseline and 3 or 6 months
Change from baseline in severity of depressive symptoms at 3 months
Time frame: baseline and 3 months
Change from baseline in severity of depressive symptoms at 12 months
Time frame: baseline and 12 months
Remission rates from anxiety-related disorder at post-treatment
Time frame: 3 or 6 months
Remission rates from anxiety-related disorder at 12 months
Time frame: 12 months
New-onset anxiety-related or depressive disorder post-treatment
Time frame: baseline, 3 or 6 months
New-onset anxiety-related or depressive disorder at 12 months
Time frame: 12 months
Productivity costs over 12 months
Time frame: 3months, 6months, 12 months
Medical costs over 12 months
Time frame: 3months, 6months, 12 months
Change from baseline in health-related quality of life over 12 months
Time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months, 12 months
Drop-out rates at post-treatment
Time frame: 3 or 6 months
Patient satisfaction at post-treatment
Time frame: 3 or 6 months
Negative effects of psychotherapy
Time frame: 3 or 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- 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.
Neeltje Batelaan, PhD study director
Amsterdam UMC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) in people with Anxiety Disorders and Obsessive-Compulsive Disorder, run by Amsterdam UMC, location VUmc at 6 sites in Netherlands.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Area Under the health and disability Curve at 6 months (time frame: baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.