Obsessive-Compulsive DisorderNCT05528224
Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial
A study testing stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU) in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Mar 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years
- Satisfied with the diagnostic criteria for OCD in DSM-5.
- 16≤YBOCS score ≤31
- Taking medication stably for 8 weeks
- Education level ⩾6 years
- Has sufficient audiovisual skills to complete the necessary examinations for the study.
- Right-handed (this criterion is for fMRI subjects only)
- Subjects and their guardians understood the study and signed informed consent.
Who cannot join
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- Obsessive-compulsive symptoms were too severe to participate in the experiment.
- High risk of suicide.
- Severe central system or physical disease
- Pregnant women or women that getting ready for being pregnant and lactating.
- Other treatments being performed.
- Uncooperative or unable to complete treatment
- With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial
The goal of this clinical trial is to learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder (OCD) in China.
The main questions it aims to answer are:
Read more
question 1: Whether the efficacy of SC-ICBT is noninferior to CBGT and TAU for OCD?
question 2: Whether SC-ICBT is more cost-effective than CBGT and TAU for OCD?
Participants will receive treatment (SC-ICBT or CBGT or TAU) for 6 weeks.
Prior to the main study, we conduct a non-randomized pilot study to explore the efficacy and cost-effectiveness of SC-ICBT related to CBGT for adults with OCD in China.
Read the detailed description
Internet-based cognitive behavioral therapy (ICBT) integrates the Internet and cognitive behavioral therapy, which enables patients to participate in different treatment modules online. ICBT has been proved to be an effective way to improve the symptoms of OCD patients with lower cost. Stepped care model (SCM) allows to better balance the efficacy of treatment and the cost of treatment.
In the main study, the investigators plan to develop an intervention pattern of stepped-care Internet-Based cognitive behavioral therapy (SC-ICBT): After individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly. This study will be a randomized, controlled, assessor-blinded trial of three groups in OCD: Stepped-care Internet-based Cognitive Behavioral Therapy (SC-ICBT) combined with medication, Cognitive Behavioral Group Therapy (CBGT) combined with medication, and conventional medical treatment (TAU). The study aims to investigate the efficacy and cost-effectiveness of SC-ICBT related to CBGT and TAU for adults with OCD in China.
To initially validate the feasibility of SC-ICBT in Chinese patients with OCD, the investigators plan to firstly conduct a small, non-randomized pilot study prior to the main study. In the pilot study, patients assigned to SC-ICBT group will begin with self-guided ICBT, followed by an assessment of their treatment outcomes at week 3, with non-responders being escalated to a higher intensity of treatment, and additional therapist-guided ICBT in the following three weeks.
In the main study, the investigators plan to recruit 114 OCD patients and randomly assigns them to the SC-ICBT group, CBGT group, and TAU group for treatment of 6 weeks and follow-up of 3 months.
While in the pilot study, 46 OCD patients will be recruited and assigned to the SC-ICBT group or CBGT group based on their autonomous will.
Questionnaires, scales, behavior experiments and other experimental materials will be used to evaluate the intervention effect of 6-week SC-ICBT on obsessive and compulsive symptoms, cognitive function and quality of life of OCD patients as well as patients' and therapists' cost.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT), conventional medical treatment (TAU)
- Keywords
- Obsessive-Compulsive Disorder, Stepped-care Internet-based Cognitive Behavioral Therapy, Cost-effectiveness, Randomized Controlled Trial
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)Other
OCD patients will take part in four structured online lessons for 6 weeks. Lesson one: Psychological Health Education, including the knowledge about OCD, SUDs and other related information.
Lesson two: Exposure and Response Prevention (ERP), including the knowledge about ERP, exposure item list and other related information.
Lesson three: Practice of Exposure and Response Prevention. Patients are asked to perform ERP practice based on what they have learned previously: practice at least once a day, a day about one hour all together. On this basis, in the main study, patients with severe obsessive and compulsive symptoms(Y-BOCS≥24) will be provided with extra therapist-guided ICBT: twice a week, about an hour one time. While in the pilot study, non-responders at week 3(YBOCS score reduction rate<25%) will be provided with extra therapist-guided ICBT.
Lesson four: Practice retrospection and relapse prevention.
Cognitive Behavioral Group Therapy (CBGT)Other
OCD patients will be asked to come to Shanghai Mental Health Center to take part in the offline CBT group. Each group will be treated for 6 weeks, twice a week for 2 hours each time. The treatment was supervised by an experienced CBGT therapist. The structure of the course basically corresponds with the SC-ICBT group.
conventional medical treatment (TAU)Drug
In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline and fluvoxamine) as well as citalopram and escitalopram. The second-generation atypical antipsychotics may also be combined as a potentiator if the patient requires.
The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.
| Study group | Role | What they receive |
|---|---|---|
| stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication | Experimental | In the main study, after individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly while they will continue with the medications they already have.
In the pilot study, 23 OCD patients will be assigned to SC-ICBT group based on their autonomous will. They will begin with self-guided ICBT, followed by an assessment of their treatment outcomes at week 3, with non-responders being escalated to a higher intensity of treatment, and additional therapist-guided ICBT in the following three weeks. During the 6-week treatment they will continue with the medications they already have. Receives: Other: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT); Drug: conventional medical treatment (TAU) |
| Cognitive Behavioral Group Therapy (CBGT) combined with medication | Active comparator | In the main study, OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have.
In the pilot study, 23 OCD patients will be assigned to CBGT group based on their autonomous will. They will receive the same CBGT intervention as in the main study while they will continue with the medications they already have. Receives: Other: Cognitive Behavioral Group Therapy (CBGT); Drug: conventional medical treatment (TAU) |
| conventional medical treatment (TAU) | Active comparator | In the main study, OCD patients will be treated as usual. Namely, they will continue with the medications they already have.
This group is not present in the pilot study, as both SC-ICBT group and CBGT group combines medications. We suppose that the mere use of SC-ICBT group compared to CBGT group (a commonly used psychotherapy in Chinese clinical practice) is sufficient to draw conclusions about the feasibility of SC-ICBT in in adults with OCD in China.
However, in order to further validate the economic benefits of SC-ICBT, we chose to set TAU group in the main study. Receives: Drug: conventional medical treatment (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)
YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity.
Measured: Change from Baseline at 6weeks
Secondary outcomes (3)
Change of Florida Obsessive-Compulsive Inventory (FOCI)
FOCI, a self-rating scale, is used to assess the severity of obsessive-compulsive symptoms within one month, which contains 20 items. The first 15 items are evaluated the symptoms by yes and no, and the last 5 items are evaluated the severity of symptoms on 0-4 five-point scale.
Measured: Change from Baseline at 6weeks
Change of Self-rating Depression Scale (SDS)
Self-rating Depression Scale (SDS) was developed by William W. K. Zung of Duke University Medical School in 1965. It is one of the most widely used self-rating depression scales. It is used to measure the severity of depression and its change in treatment.
Measured: Change from Baseline at 6weeks
Change of Self-rating Anxiety Scale (SAS)
The Self-rating Anxiety Scale (SAS) is very similar to the Self-rating Depression Scale (SDS) from the scale construction to the evaluation method. It is a very simple clinical tool to analyze the subjective anxiety symptoms of patients. It is suitable for adults with anxiety symptoms and has a wide range of application.
Measured: Change from Baseline at 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Sep 2022
- Primary completion30 Aug 2023
- Study completion31 Mar 2024
Why it stopped: Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Fan, Doctor, Study chair, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528224
- Sponsor's protocol ID
- OCDICBT2022-36
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2022
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05528224
- Acronym / sponsor ID
- OCDICBT2022-36
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-Compulsive Disorder, Stepped-care Internet-based Cognitive Behavioral Therapy, Cost-effectiveness, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Sep 2022 (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 learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder (OCD) in China.
The main questions it aims to answer are:
question 1: Whether the efficacy of SC-ICBT is noninferior to CBGT and TAU for OCD?
question 2: Whether SC-ICBT is more cost-effective than CBGT and TAU for OCD?
Participants will receive treatment (SC-ICBT or CBGT or TAU) for 6 weeks.
Prior to the main study, we conduct a non-randomized pilot study to explore the efficacy and cost-effectiveness of SC-ICBT related to CBGT for adults with OCD in China.
Detailed description
Internet-based cognitive behavioral therapy (ICBT) integrates the Internet and cognitive behavioral therapy, which enables patients to participate in different treatment modules online. ICBT has been proved to be an effective way to improve the symptoms of OCD patients with lower cost. Stepped care model (SCM) allows to better balance the efficacy of treatment and the cost of treatment.
In the main study, the investigators plan to develop an intervention pattern of stepped-care Internet-Based cognitive behavioral therapy (SC-ICBT): After individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly. This study will be a randomized, controlled, assessor-blinded trial of three groups in OCD: Stepped-care Internet-based Cognitive Behavioral Therapy (SC-ICBT) combined with medication, Cognitive Behavioral Group Therapy (CBGT) combined with medication, and conventional medical treatment (TAU). The study aims to investigate the efficacy and cost-effectiveness of SC-ICBT related to CBGT and TAU for adults with OCD in China.
To initially validate the feasibility of SC-ICBT in Chinese patients with OCD, the investigators plan to firstly conduct a small, non-randomized pilot study prior to the main study. In the pilot study, patients assigned to SC-ICBT group will begin with self-guided ICBT, followed by an assessment of their treatment outcomes at week 3, with non-responders being escalated to a higher intensity of treatment, and additional therapist-guided ICBT in the following three weeks.
In the main study, the investigators plan to recruit 114 OCD patients and randomly assigns them to the SC-ICBT group, CBGT group, and TAU group for treatment of 6 weeks and follow-up of 3 months.
While in the pilot study, 46 OCD patients will be recruited and assigned to the SC-ICBT group or CBGT group based on their autonomous will.
Questionnaires, scales, behavior experiments and other experimental materials will be used to evaluate the intervention effect of 6-week SC-ICBT on obsessive and compulsive symptoms, cognitive function and quality of life of OCD patients as well as patients' and therapists' cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication | Experimental | Other: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Drug: conventional medical treatment (TAU)In the main study, after individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly while they will continue with the medications they already have. In the pilot study, 23 OCD patients will be assigned to SC-ICBT group based on their autonomous will. They will begin with self-guided ICBT, followed by an assessment of their treatment outcomes at week 3, with non-responders being escalated to a higher intensity of treatment, and additional therapist-guided ICBT in the following three weeks. During the 6-week treatment they will continue with the medications they already have. |
| Cognitive Behavioral Group Therapy (CBGT) combined with medication | Active comparator | Other: Cognitive Behavioral Group Therapy (CBGT), Drug: conventional medical treatment (TAU)In the main study, OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have. In the pilot study, 23 OCD patients will be assigned to CBGT group based on their autonomous will. They will receive the same CBGT intervention as in the main study while they will continue with the medications they already have. |
| conventional medical treatment (TAU) | Active comparator | Drug: conventional medical treatment (TAU)In the main study, OCD patients will be treated as usual. Namely, they will continue with the medications they already have. This group is not present in the pilot study, as both SC-ICBT group and CBGT group combines medications. We suppose that the mere use of SC-ICBT group compared to CBGT group (a commonly used psychotherapy in Chinese clinical practice) is sufficient to draw conclusions about the feasibility of SC-ICBT in in adults with OCD in China. However, in order to further validate the economic benefits of SC-ICBT, we chose to set TAU group in the main study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 and 50 years
- Satisfied with the diagnostic criteria for OCD in DSM-5.
- 16≤YBOCS score ≤31
- Taking medication stably for 8 weeks
- Education level ⩾6 years
Key exclusion criteria (8 listed)
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
- Obsessive-compulsive symptoms were too severe to participate in the experiment.
- High risk of suicide.
- Severe central system or physical disease
- Pregnant women or women that getting ready for being pregnant and lactating.
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 |
|---|---|---|
| stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)OCD patients will take part in four structured online lessons for 6 weeks. Lesson one: Psychological Health Education, including the knowledge about OCD, SUDs and other related information. Lesson two: Exposure and Response Prevention (ERP), including the knowledge about ERP, exposure item list and other related information. Lesson three: Practice of Exposure and Response Prevention. Patients are asked to perform ERP practice based on what they have learned previously: practice at least once a day, a day about one hour all together. On this basis, in the main study, patients with severe obsessive and compulsive symptoms(Y-BOCS≥24) will be provided with extra therapist-guided ICBT: twice a week, about an hour one time. While in the pilot study, non-responders at week 3(YBOCS score reduction rate<25%) will be provided with extra therapist-guided ICBT. Lesson four: Practice retrospection and relapse prevention. | Other | stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication |
| Cognitive Behavioral Group Therapy (CBGT)OCD patients will be asked to come to Shanghai Mental Health Center to take part in the offline CBT group. Each group will be treated for 6 weeks, twice a week for 2 hours each time. The treatment was supervised by an experienced CBGT therapist. The structure of the course basically corresponds with the SC-ICBT group. | Other | Cognitive Behavioral Group Therapy (CBGT) combined with medication |
| conventional medical treatment (TAU)In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline and fluvoxamine) as well as citalopram and escitalopram. The second-generation atypical antipsychotics may also be combined as a potentiator if the patient requires. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual. | Drug | Cognitive Behavioral Group Therapy (CBGT) combined with medication, conventional medical treatment (TAU), stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication |
Primary outcome
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)
Time frame: Change from Baseline at 6weeks
YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity.
3 secondary outcomes
Change of Florida Obsessive-Compulsive Inventory (FOCI)
Time frame: Change from Baseline at 6weeks
Change of Self-rating Depression Scale (SDS)
Time frame: Change from Baseline at 6weeks
Change of Self-rating Anxiety Scale (SAS)
Time frame: Change from Baseline at 6weeks
Results and safety
The study was stopped early (reason given: Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
Qing Fan, Doctor study chair
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stepped-care Internet-based cognitive behavioral therapy(SC-ICBT), Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (TAU) in people with Obsessive-Compulsive Disorder, run by Shanghai Mental Health Center at 1 site in China.
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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 21 Jan 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 China. 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 was stopped early (reason given: Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness). Results are not available in the source record.
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?
Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS) (time frame: Change from Baseline at 6weeks). 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 21 Jan 2026.