Post Traumatic Stress DisorderNCT05934175
Intensive Treatment Versus Standard Weekly Prolonged Exposure for Adults With Post-Traumatic Stress Disorder
A study testing Intensive treatment with prolonged exposure and Weekly delivered prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to compare a novel, massed treatment format of prolonged exposure to gold standard trauma focused cognitive behavioral therapy (weekly delivered prolonged exposure) for post-traumatic stress disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Intensive treatment with prolonged exposure and Weekly delivered prolonged exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- 4 Sep 2023to 20 Jun 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
- 18 years of age or above,
- Primary PTSD diagnosis
- Fluent in Swedish
- Sign informed consent
- Able to attend either I-PE or 15 weekly sessions of PE
Who cannot join
- Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention
- Ongoing evidence-based trauma-focused psychological treatment
- Ongoing trauma-related threat (e.g. living with a violent spouse)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Traumaprogrammet, Psykiatri Sydväst
Stockholm
Maria Bragesjö, PhD, maria.bragesjo@ki.se
About this study
Official title: Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial
The goal of this clinical trial is to compare a novel, massed treatment format of prolonged exposure to gold standard trauma focused cognitive behavioral therapy (weekly delivered prolonged exposure) for post-traumatic stress disorder.
The objective with this study is to investigate efficacy, mechanisms of change and cost effectiveness of intensive prolonged exposure (I-PE) in regular Swedish psychiatric care.
Adult patients with post-traumatic stress disorder will be randomly assigned to receive either gold standard prolonged exposure weekly for 15 weeks or 5 days of intensive treatment with the addition of three booster sessions dispersed 1, 2 and 4 weeks after completion of the massed treatment period. Qualitative interviews will be conducted with therapists to explore their experiences of delivering intensive treatment for PTSD, with particular focus on perceived benefits and challenges, clinical processes, patient engagement, and the impact of the intensive format on therapeutic work.
Read the detailed description
PTSD is one of the most common psychiatric disorders and is strongly linked to subsequent psychiatric and medical problems. Trauma-focused cognitive behavioral therapy (CBT-T) such as prolonged exposure is an effective treatment for PTSD and is recommended in most clinical guidelines as first-line treatment. However, the treatment period often lasts 3-5 months, which is believed to be a contributing factor to the high dropout rate that has suggested to be a major factor to why a significant proportion of patients fail to demonstrate clinically significant symptom change. In response, more intensive treatment approaches i have been developed based on the notion that frequency of treatment sessions are a potential mechanism for retention. Preliminary research shows intensive trauma focused treatment (I-PE) to be as effective as when the treatment is delivered by weekly sessions, but with the advantage that the recovery rate is faster and the proportion of patients who drop out decreases.
Before this type of treatment can be offered in regular care in Sweden, it needs to be further evaluated. If I-PE would be found to effective, this project has the potential to be the first step towards implementation of a novel, superior and more cost-effective mode of treatment delivery for adults with PTSD in regular Swedish health care. The intensive treatment format has yet to be directly compared to gold-standard CBT-T, and that is what we propose to do in this trial.
The study is a single-blind, parallel-group superiority randomized controlled trial with 140 patients (70 per arm) will compare intensive prolonged exposure to gold standard weekly delivered prolonged exposure. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesis that participants in the massed treatment format will improve faster than patients that receive weekly sessions, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.
The trial will also be preregistered at the Open Science Framework.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Intensive treatment with prolonged exposure, Weekly delivered prolonged exposure
- Keywords
- PTSD, intensive treatment, prolonged exposure, massed treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive treatment with prolonged exposureBehavioural
Intensive treatment with prolonged exposure
Weekly delivered prolonged exposureBehavioural
Weekly delivered prolonged exposure sessions for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment with prolonged exposure | Experimental | Intensive prolonged exposure delivered for five consecutive days comprising nine individual sessions and five group sessions followed by three individual session one, two and four weeks afterwards. Receives: Behavioral: Intensive treatment with prolonged exposure |
| Weekly delivered prolonged exposure | Active comparator | 15 weekly delivered, individual prolonged exposure sessions (gold standard treatment) Receives: Behavioral: Weekly delivered prolonged exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment
Secondary outcomes (11)
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
Measured: Baseline, through the treatment period up to 15 weeks after inclusion and at 1-month, 6-month and 12-month post-treatment
Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
The ITQ includes six items measuring each PTSD symptom cluster and these items measure how bothersome each symptom has been in the past month. The ITQ also includes six items measuring each 'Disturbance in Self-Organization' (DSO) symptom in complex PTSD. These items measure how a respondent typically feels, thinks about oneself, and relates to others. The PTSD and DSO symptoms are accompanied by three items measuring associated functional impairments in the domains of social, occupation, and other important areas of life. All items are answered on a 5-point Likert scale ranging from 0 (Not at all) to 4 (Extremely). Thus, PTSD and DSO symptom scores range from 0 to 24 and CPTSD symptom scores range from 0 to 48. Higher scores represents more PTSD and complex PTSD symptoms.
Measured: Baseline, through the treatment period and 1-month, 6-month and 12-month post-treatment
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a widely used and well-validated instrument for measuring the severity of depressive symptoms. Scores are calculated based on how frequently a person experiences 9 symptoms of depression ranging from "not at all" response is scored as 0; "several days" response is 1; "more than half the days" response is 2; and "nearly every day" response is 3. Higher scores represents more depressive symptoms.
Measured: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Change in quality of life measured by Euroqol, EQ-5D
Change in overall health from baseline to post treatment and follow up . EQ-5D is a standardized self-report measure of overall health status measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a three-level scale: 1 having no problems, 2 having some problems and 3 having extreme problems. A higher score indicate worse severity.
Measured: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Change in Assessing Quality of Life 6 Dimensions (AQoL-6D)
Used to assess cost-effectiveness. 20 questions that assess different aspects of quality of life. The AQoL provides a utility score that ranges from 1.00 (full health) to 0.00 (death-equivalent health states) to -0.04 (health states worse than death).
Measured: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Adverse events related to treatment measured by the Negative effects questionnaire
Self-rated questionnaire on negative effects. It contains 32 items that are scored on a five point Likert-scale (0-4) and differentiates between negative effects that are attributed to treatment and those possibly caused by other circumstances. The total score of the NEQ ranges from 0 to 80 points, a higher score reflects more negative effects.
Measured: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Adverse events
Open ended question about recurrence of any adverse event
Measured: Each treatment session and assessment point through study completion up to the 12-month follow up.
Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Self-rated questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder. The TIC-P questionnaire measures costs in two dimensions: use of health resources and loss of productivity. Lower cost is better.
Measured: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
The CSQ-8 yields a single score measuring a single dimension of overall satisfaction. An "overall score" is calculated by summing the score on each of the eight scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Measured: Immediately after treatment completion
Number of drop-outs from treatment and assessment
Number of drop outs from treatment and assessment points will be calculated in each arm.
Measured: Baseline up to the 12-month follow up.
Qualitative interviews with therapist delivering the intervention
Therapist experiences of delivering intensive PTSD treatment, assessed through semi-structured qualitative interviews.
Measured: Assessed after completion of at least one full course of intensive PTSD treatment, during the study recruitment period (up to 30 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start4 Sep 2023
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prolonged exposure will be offered in a massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 1, 2 and 4 weeks afterwards.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Maria Bragesjo, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934175
- Sponsor's protocol ID
- 2023-02329-01
- Other IDs
- 2023
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2023
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bragesjo M, Fina B, Ivanova E, Ivanov VZ, Ruck C. Study protocol for a single-blind, parallel-group, randomized, controlled superiority trial of intensive versus weekly delivered prolonged exposure for adults with post-traumatic stress disorder. Trials. 2024 Jun 12;25(1):381. doi: 10.1186/s13063-024-08218-2.
PubMed 38867309
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Mechanisms of Change and Cost Effectiveness of Intensive Exposure-based Treatment for PTSD: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05934175
- Acronym / sponsor ID
- 2023-02329-01
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, intensive treatment, prolonged exposure, massed treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 6 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 a novel, massed treatment format of prolonged exposure to gold standard trauma focused cognitive behavioral therapy (weekly delivered prolonged exposure) for post-traumatic stress disorder.
The objective with this study is to investigate efficacy, mechanisms of change and cost effectiveness of intensive prolonged exposure (I-PE) in regular Swedish psychiatric care.
Adult patients with post-traumatic stress disorder will be randomly assigned to receive either gold standard prolonged exposure weekly for 15 weeks or 5 days of intensive treatment with the addition of three booster sessions dispersed 1, 2 and 4 weeks after completion of the massed treatment period. Qualitative interviews will be conducted with therapists to explore their experiences of delivering intensive treatment for PTSD, with particular focus on perceived benefits and challenges, clinical processes, patient engagement, and the impact of the intensive format on therapeutic work.
Detailed description
PTSD is one of the most common psychiatric disorders and is strongly linked to subsequent psychiatric and medical problems. Trauma-focused cognitive behavioral therapy (CBT-T) such as prolonged exposure is an effective treatment for PTSD and is recommended in most clinical guidelines as first-line treatment. However, the treatment period often lasts 3-5 months, which is believed to be a contributing factor to the high dropout rate that has suggested to be a major factor to why a significant proportion of patients fail to demonstrate clinically significant symptom change. In response, more intensive treatment approaches i have been developed based on the notion that frequency of treatment sessions are a potential mechanism for retention. Preliminary research shows intensive trauma focused treatment (I-PE) to be as effective as when the treatment is delivered by weekly sessions, but with the advantage that the recovery rate is faster and the proportion of patients who drop out decreases.
Before this type of treatment can be offered in regular care in Sweden, it needs to be further evaluated. If I-PE would be found to effective, this project has the potential to be the first step towards implementation of a novel, superior and more cost-effective mode of treatment delivery for adults with PTSD in regular Swedish health care. The intensive treatment format has yet to be directly compared to gold-standard CBT-T, and that is what we propose to do in this trial.
The study is a single-blind, parallel-group superiority randomized controlled trial with 140 patients (70 per arm) will compare intensive prolonged exposure to gold standard weekly delivered prolonged exposure. The primary outcome is the blind-rater administered Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).
Secondary outcomes are cost effectiveness, speed of response, response and remission rates, dropout rate, and negative effects. The investigators hypothesis that participants in the massed treatment format will improve faster than patients that receive weekly sessions, but for the rest of the secondary outcomes, the investigators have no directed hypotheses.
The trial will also be preregistered at the Open Science Framework.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prolonged exposure will be offered in a massed format with a total of nine 60 minutes sessions of imaginal exposure and processing and five 2 hour group session with psychoeducation, rationales and in vivo exposure during one treatment week followed by three individual 60 minutes sessions 1, 2 and 4 weeks afterwards.
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment with prolonged exposure | Experimental | Behavioral: Intensive treatment with prolonged exposureIntensive prolonged exposure delivered for five consecutive days comprising nine individual sessions and five group sessions followed by three individual session one, two and four weeks afterwards. |
| Weekly delivered prolonged exposure | Active comparator | Behavioral: Weekly delivered prolonged exposure15 weekly delivered, individual prolonged exposure sessions (gold standard treatment) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or above,
- Primary PTSD diagnosis
- Fluent in Swedish
- Sign informed consent
- Able to attend either I-PE or 15 weekly sessions of PE
Key exclusion criteria (4 listed)
- Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- Serious mental health symptoms, such as mania, psychosis, alcohol, or substance use disorders or current suicide risk warranting immediate clinical attention
- Ongoing evidence-based trauma-focused psychological treatment
- Ongoing trauma-related threat (e.g. living with a violent spouse)
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 |
|---|---|---|
| Intensive treatment with prolonged exposureIntensive treatment with prolonged exposure | Behavioural | Intensive treatment with prolonged exposure |
| Weekly delivered prolonged exposureWeekly delivered prolonged exposure sessions for 15 weeks | Behavioural | Weekly delivered prolonged exposure |
Primary outcome
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)
Time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment
The CAPS-5 is structured interview that assesses the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria for PTSD (Weathers et al., 2013). Each item is rated on a severity scale ranging from 0 (Absent) to 4 (Extreme/incapacitating) and combines information about frequency and intensity for each of the 20 symptoms. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
11 secondary outcomes
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
Time frame: Baseline, through the treatment period up to 15 weeks after inclusion and at 1-month, 6-month and 12-month post-treatment
Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).
Time frame: Baseline, through the treatment period and 1-month, 6-month and 12-month post-treatment
Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Change in quality of life measured by Euroqol, EQ-5D
Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Change in Assessing Quality of Life 6 Dimensions (AQoL-6D)
Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Adverse events related to treatment measured by the Negative effects questionnaire
Time frame: Immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Adverse events
Time frame: Each treatment session and assessment point through study completion up to the 12-month follow up.
Change in Treatment Inventory of Costs in Psychiatric Patients (TIC-P)
Time frame: Baseline, immediately after treatment completion, 1-month, 6-month and 12-month post-treatment
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
Time frame: Immediately after treatment completion
Number of drop-outs from treatment and assessment
Time frame: Baseline up to the 12-month follow up.
Qualitative interviews with therapist delivering the intervention
Time frame: Assessed after completion of at least one full course of intensive PTSD treatment, during the study recruitment period (up to 30 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 7 Apr 2026.
- Derived from this study: PubMed 38867309Bragesjo M, Fina B, Ivanova E, Ivanov VZ, Ruck C. Study protocol for a single-blind, parallel-group, randomized, controlled superiority trial of intensive versus weekly delivered prolonged exposure for adults with post-traumatic stress disorder. Trials. 2024 Jun 12;25(1):381. doi: 10.1186/s13063-024-08218-2.
- Individual participant dataSharing planned: No
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive treatment with prolonged exposure and Weekly delivered prolonged exposure in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
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: looking for participants now, as of the sponsor's last update on 7 Apr 2026. 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 Sweden. 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?
Contact Maria Bragesjö, PhD (0703399387, maria.bragesjo@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5) (time frame: Baseline, 1-month (primary endpoint), 6-month and 12-month post-treatment). 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 NCT05934175, which also lists 1 linked publication.
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 7 Apr 2026.