Suicidal IdeationNCT04770168
Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial
A study testing Cognitive Behavioral Therapy Curriculum in people with Suicidal Ideation and Suicidal and Self-injurious Behavior, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation, Suicidal and Self-injurious Behavior, Suicide Attempt
- What is being tested?
- Cognitive Behavioral Therapy Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,204 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to Sep 2026
- 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 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Only schools with Grade 7 and 8 classrooms (if requested, we may allow high school teachers/students in Grade 9 - 12 to participate as well)
- Participants must be able to speak and read fluent English
- Participants must be willing to complete demographic and clinical self-report questionnaires on anxiety, depression, and general well-being before the intervention and at each timepoint.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mark Sinyor, MD, 416-480-4870, mark.sinyor@sunnybrook.ca
About this study
School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. CBT teaches youth about the relationship between their thoughts, feelings, and behaviours, and provides strategies for managing distress. However, there is no established standard mental health literacy curriculum in Ontario. The investigators developed a school-based mental health literacy program that uses the third book in the Harry Potter series ('Harry Potter and the Prisoner of Azkaban') to teach students how to cope with distress through CBT skills. This study will determine whether the Harry Potter-based mental health literacy curriculum diminishes suicidality in students. The study will also determine whether the curriculum decreases depression and anxiety symptoms and improves well-being.
The 3-month intervention is a manual-based curriculum which teaches CBT skills in English class. The website includes video and text-based onboarding to train teachers on all the lessons. Youth complete online exercises for each unit and teachers follow a manual with checklists to preserve high fidelity and standardization of core learning.
Participating classes will be randomized in 1:1 fashion to receive the curriculum in the fall (~Oct-Dec) or the winter (~Feb-Apr). The study will use a stepped-wedge design to introduce the curriculum to classes sequentially testing whether students who receive it in fall will improve at mid-year and those in winter will catch up by year-end. The winter group is included as a "maturational" control to account for changes over the school year that are independent of the intervention and so that order effects of curriculum delivery can be tested. For this design, questionnaires will be administered four times throughout the school year (once before and after each semester), and once more the following year to measure duration of response. At each timepoint, subjects will complete validated questionnaires about suicide attempts and self-harm, anxiety, depression, well-being, and health services usage. Students may also choose to participate in focus groups to collect qualitative data on their experience with the curriculum. With additional consent (Ontario youth only), we will also collect aggregate lists of the Ontario Health Insurance Plan (OHIP) numbers for participating students. These will be provided to the Institute of Clinical Evaluative Sciences (ICES) who will identify sex, age and pre-existing healthcare utilization matched controls from regions that do not adopt the curriculum.
Read the detailed description
Emerging evidence demonstrates that mental health literacy is a critical avenue for primary prevention of mental disorders as it increases awareness and recognition, decreases stigma, and encourages help-seeking. The largest mental health literacy study was conducted in Scandinavia and found that the combination of two lectures, three hours of role-play and an informational booklet reduced suicidal ideation and attempts after one year by approximately half in a cohort of more than 2,000 teenagers. The mental health literacy curriculum was the only intervention that was significantly better than a control group. The intervention has been piloted in more than 2,000 students in Ontario. The intervention is a 'literature study' taught over approximately 3 months in which a class reads the book and learns how distress and depression can manifest. The investigators have conducted two studies - a simple before and after design with 78 participants and a controlled trial with 200 participants who received the intervention and 230 wait list controls. Both indicated an intervention effect on suicide scores as well as improvements on a scale of symptoms of borderline personality disorder (e.g. emotional dysregulation), and depression and anxiety scores). These early findings suggest that this intervention may be a unique way of preventing suicidal ideation and attempts, and improving the mental health of youth across Canada and beyond.
The primary objective of the study is to determine whether the Harry Potter-based cognitive behavioural therapy curriculum diminishes suicidality (ideation and attempts) in students who receive it.
The primary hypothesis is that students receiving the curriculum will have a clinically and statistically significant reduction in rates (≥50%) on a composite measure of a) self-reported suicidal ideation, and b) self-reported suicide attempts.
Furthermore, the secondary objectives for the study are:
- To determine whether the Harry Potter-based cognitive behavioural therapy curriculum decreases depression and anxiety symptoms and improves wellbeing immediately following the curriculum and approximately 6 months later.
- To determine student and teacher satisfaction with the Harry Potter-based cognitive behavioural therapy curriculum
- To create a website which achieves sufficient youth and teacher acceptability and 'youth friendliness' for widespread implementation
The secondary hypotheses are as follows:
- Students receiving the curriculum will have a clinically and statistically significant reduction (≥50%) in their presentation to emergency services for self-harm/suicide attempts according to Ontario health administrative data (held in the Institute for Clinical Evaluative Services (ICES) repository). This is only applicable to research participants in Ontario.
- Students receiving the curriculum will have clinically meaningful, significantly lower scores (≥25%) on validated instruments for youth depression and anxiety (the Revised Children's Anxiety and Depression Scale - RCADS), and wellbeing (the Life Problems Inventory - LPI) immediately after receiving it. Moreover, students will report a significant improvement (≥25%) on the Coping Scale for Children and Youth (CSCY) questionnaire.
- Students in the first cohort (students who receive the curriculum in the fall semester) will have clinically meaningful, significantly lower scores (≥25%) on validated instruments for youth depression and anxiety (the Revised Children's Anxiety and Depression Scale - RCADS) and wellbeing (the Life Problems Inventory - LPI; Coping Scale for Children and Youth - CSCY) than the second cohort (students who receive the curriculum in the winter semester) at the mid-year point, but the two groups will not differ statistically at year end (i.e. the second cohort will catch up to the first).
- There will be no significant difference between mid-year and year-end measures for the first cohort (i.e., gains will persist at approximately 6 months).
- Student and teacher scores will both be high (mean ≥6 on 7-point Likert scales) on satisfaction questionnaires asking the degree to which they think they/their students benefited from the intervention, enjoyed the intervention, and would recommend it to others.
- Student focus group data will reflect that students have experienced a qualitative improvement in wellbeing, knowledge of mental disorders and resilience following the curriculum.
- Teacher interview data will reflect that teachers found the curriculum easy to implement and useful for imparting both mental health and general literacy to their students.
- Students and teachers receiving the curriculum will achieve a mean score of ≥4 per question on a 5-point Likert-based questionnaire assessing acceptability and satisfaction as well as positive qualitative feedback.
- Being tested
- Cognitive Behavioral Therapy Curriculum
- Keywords
- Suicidal ideation, Suicide attempts, Self-harm, Mental health literacy curriculum, School-based intervention, Cognitive behavioral therapy
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy CurriculumBehavioural
The 3-month Harry Potter curriculum is delivered by trained teachers and includes lessons on a) risk factors that can contribute to emotional distress, b) how depression and anxiety manifest and how to access support/treatment, c) cognitive distortions, how they differ from rational thoughts and basic cognitive restructuring techniques, d) crisis planning including personalized "stressbusters" and "hope kits", and e) how to be resilient.
| Study group | Role | What they receive |
|---|---|---|
| CBT Curriculum - First Cohort | Experimental | Students will receive the 3-month cognitive behavioral therapy curriculum in the first half of the academic year. Receives: Behavioral: Cognitive Behavioral Therapy Curriculum |
| CBT Curriculum - Second Cohort (Waitlist Controls) | Experimental | Students will receive the current school board curriculum as usual for the first half of the academic year, serving as wait-list controls. Since this is a stepped wedge trial, the winter cohort will receive the identical intervention as the fall cohort in the second half of academic year. Receives: Behavioral: Cognitive Behavioral Therapy Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Self-Reported Suicidal Ideation and Attempts
Composite includes self-reported suicidal ideation and self-reported suicide attempts, assessed by questions in the Life Problems Inventory (LPI).
Measured: Approximately 1-year period of study
Secondary outcomes (6)
Presentation of Self-harm and Suicide Attempts
Presentations to emergency services for self-harm/suicide attempts according to Ontario health administrative data (held in the Institute for Clinical Evaluative Services (ICES) repository). This is only applicable to research participants in Ontario.
Measured: 1-year period of study
Revised Children's Anxiety and Depression Scale
Assesses youth depression and anxiety. Scale consists of 6 subscales, including Social Phobia (minimum score = 0, maximum score = 27), Panic Disorder (minimum score = 0, maximum score = 27), Major Depression (minimum score = 0, maximum score = 30), Separation Anxiety (minimum score = 0, maximum score = 21), Generalized Anxiety Disorder (minimum score = 0, maximum score = 18), and Obsessive-Compulsive (minimum score = 0, maximum score = 18). Higher scores indicate worse outcome.
Measured: Approximately 1-year period of study
Life Problems Inventory Questionnaire
Assesses wellbeing and features borderline personality disorder. Minimum total score = 60. Maximum total score = 300. Higher scores indicate greater dysfunction and worse outcome. Subscales include confusion about self (minimum score = 15, maximum score = 75), impulsivity (minimum score = 15, maximum score = 75), emotional dysregulation (minimum score = 15, maximum score = 75), and interpersonal chaos (minimum score = 15, maximum score = 75).
Measured: Approximately 1-year period of study
Coping Scale for Children and Youth Questionnaire
Assesses coping behaviours. Subscales include assistance seeking, cognitive-behavioural problem solving, cognitive avoidance, and behavioural avoidance. Higher scores indicate greater use of that coping dimension.
Measured: Approximately 1-year period of study
Student Satisfaction Questionnaire and Focus Group
Composite of responses from self-report questionnaires and focus groups which assesses the degree to which students benefitted from the intervention, enjoyed the intervention, and would recommend to others. Higher scores indicate greater satisfaction.
Measured: Approximately 1-year period of study
Teacher Satisfaction Questionnaire and Focus Group
Composite of responses from self-report questionnaires and focus groups which assesses the degree to which teachers think that their students benefitted from the intervention, enjoyed the intervention, and would recommend to others. Higher scores indicate greater satisfaction.
Measured: Approximately 1-year period of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a stepped wedge research design, allowing for both groups to receive the same cognitive behavioural therapy curriculum but during different time periods. Half the classes will receive the curriculum during the first half of the academic year and the rest of the classes will receive the curriculum during the second half of the academic year.
- Masking
- None (open label)
- Enrolment
- 3,204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Sinyor, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770168
- Sponsor's protocol ID
- 2200
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2021
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial
- ClinicalTrials.gov ID
- NCT04770168
- Acronym / sponsor ID
- 2200
- Keywords
- Suicidal ideation, Suicide attempts, Self-harm, Mental health literacy curriculum, School-based intervention, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,204 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Feb 2021 (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.
School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. CBT teaches youth about the relationship between their thoughts, feelings, and behaviours, and provides strategies for managing distress. However, there is no established standard mental health literacy curriculum in Ontario. The investigators developed a school-based mental health literacy program that uses the third book in the Harry Potter series ('Harry Potter and the Prisoner of Azkaban') to teach students how to cope with distress through CBT skills. This study will determine whether the Harry Potter-based mental health literacy curriculum diminishes suicidality in students. The study will also determine whether the curriculum decreases depression and anxiety symptoms and improves well-being.
The 3-month intervention is a manual-based curriculum which teaches CBT skills in English class. The website includes video and text-based onboarding to train teachers on all the lessons. Youth complete online exercises for each unit and teachers follow a manual with checklists to preserve high fidelity and standardization of core learning.
Participating classes will be randomized in 1:1 fashion to receive the curriculum in the fall (~Oct-Dec) or the winter (~Feb-Apr). The study will use a stepped-wedge design to introduce the curriculum to classes sequentially testing whether students who receive it in fall will improve at mid-year and those in winter will catch up by year-end. The winter group is included as a "maturational" control to account for changes over the school year that are independent of the intervention and so that order effects of curriculum delivery can be tested. For this design, questionnaires will be administered four times throughout the school year (once before and after each semester), and once more the following year to measure duration of response. At each timepoint, subjects will complete validated questionnaires about suicide attempts and self-harm, anxiety, depression, well-being, and health services usage. Students may also choose to participate in focus groups to collect qualitative data on their experience with the curriculum. With additional consent (Ontario youth only), we will also collect aggregate lists of the Ontario Health Insurance Plan (OHIP) numbers for participating students. These will be provided to the Institute of Clinical Evaluative Sciences (ICES) who will identify sex, age and pre-existing healthcare utilization matched controls from regions that do not adopt the curriculum.
Detailed description
Emerging evidence demonstrates that mental health literacy is a critical avenue for primary prevention of mental disorders as it increases awareness and recognition, decreases stigma, and encourages help-seeking. The largest mental health literacy study was conducted in Scandinavia and found that the combination of two lectures, three hours of role-play and an informational booklet reduced suicidal ideation and attempts after one year by approximately half in a cohort of more than 2,000 teenagers. The mental health literacy curriculum was the only intervention that was significantly better than a control group. The intervention has been piloted in more than 2,000 students in Ontario. The intervention is a 'literature study' taught over approximately 3 months in which a class reads the book and learns how distress and depression can manifest. The investigators have conducted two studies - a simple before and after design with 78 participants and a controlled trial with 200 participants who received the intervention and 230 wait list controls. Both indicated an intervention effect on suicide scores as well as improvements on a scale of symptoms of borderline personality disorder (e.g. emotional dysregulation), and depression and anxiety scores). These early findings suggest that this intervention may be a unique way of preventing suicidal ideation and attempts, and improving the mental health of youth across Canada and beyond.
The primary objective of the study is to determine whether the Harry Potter-based cognitive behavioural therapy curriculum diminishes suicidality (ideation and attempts) in students who receive it.
The primary hypothesis is that students receiving the curriculum will have a clinically and statistically significant reduction in rates (≥50%) on a composite measure of a) self-reported suicidal ideation, and b) self-reported suicide attempts.
Furthermore, the secondary objectives for the study are:
- To determine whether the Harry Potter-based cognitive behavioural therapy curriculum decreases depression and anxiety symptoms and improves wellbeing immediately following the curriculum and approximately 6 months later.
- To determine student and teacher satisfaction with the Harry Potter-based cognitive behavioural therapy curriculum
- To create a website which achieves sufficient youth and teacher acceptability and 'youth friendliness' for widespread implementation
The secondary hypotheses are as follows:
- Students receiving the curriculum will have a clinically and statistically significant reduction (≥50%) in their presentation to emergency services for self-harm/suicide attempts according to Ontario health administrative data (held in the Institute for Clinical Evaluative Services (ICES) repository). This is only applicable to research participants in Ontario.
- Students receiving the curriculum will have clinically meaningful, significantly lower scores (≥25%) on validated instruments for youth depression and anxiety (the Revised Children's Anxiety and Depression Scale - RCADS), and wellbeing (the Life Problems Inventory - LPI) immediately after receiving it. Moreover, students will report a significant improvement (≥25%) on the Coping Scale for Children and Youth (CSCY) questionnaire.
- Students in the first cohort (students who receive the curriculum in the fall semester) will have clinically meaningful, significantly lower scores (≥25%) on validated instruments for youth depression and anxiety (the Revised Children's Anxiety and Depression Scale - RCADS) and wellbeing (the Life Problems Inventory - LPI; Coping Scale for Children and Youth - CSCY) than the second cohort (students who receive the curriculum in the winter semester) at the mid-year point, but the two groups will not differ statistically at year end (i.e. the second cohort will catch up to the first).
- There will be no significant difference between mid-year and year-end measures for the first cohort (i.e., gains will persist at approximately 6 months).
- Student and teacher scores will both be high (mean ≥6 on 7-point Likert scales) on satisfaction questionnaires asking the degree to which they think they/their students benefited from the intervention, enjoyed the intervention, and would recommend it to others.
- Student focus group data will reflect that students have experienced a qualitative improvement in wellbeing, knowledge of mental disorders and resilience following the curriculum.
- Teacher interview data will reflect that teachers found the curriculum easy to implement and useful for imparting both mental health and general literacy to their students.
- Students and teachers receiving the curriculum will achieve a mean score of ≥4 per question on a 5-point Likert-based questionnaire assessing acceptability and satisfaction as well as positive qualitative feedback.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs a stepped wedge research design, allowing for both groups to receive the same cognitive behavioural therapy curriculum but during different time periods. Half the classes will receive the curriculum during the first half of the academic year and the rest of the classes will receive the curriculum during the second half of the academic year.
| Arm | Type | Receives |
|---|---|---|
| CBT Curriculum - First Cohort | Experimental | Behavioral: Cognitive Behavioral Therapy CurriculumStudents will receive the 3-month cognitive behavioral therapy curriculum in the first half of the academic year. |
| CBT Curriculum - Second Cohort (Waitlist Controls) | Experimental | Behavioral: Cognitive Behavioral Therapy CurriculumStudents will receive the current school board curriculum as usual for the first half of the academic year, serving as wait-list controls. Since this is a stepped wedge trial, the winter cohort will receive the identical intervention as the fall cohort in the second half of academic year. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Only schools with Grade 7 and 8 classrooms (if requested, we may allow high school teachers/students in Grade 9 - 12 to participate as well)
- Participants must be able to speak and read fluent English
- Participants must be willing to complete demographic and clinical self-report questionnaires on anxiety, depression, and general well-being before the intervention and at each timepoint.
Key exclusion criteria (1 listed)
- -
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 CurriculumThe 3-month Harry Potter curriculum is delivered by trained teachers and includes lessons on a) risk factors that can contribute to emotional distress, b) how depression and anxiety manifest and how to access support/treatment, c) cognitive distortions, how they differ from rational thoughts and basic cognitive restructuring techniques, d) crisis planning including personalized "stressbusters" and "hope kits", and e) how to be resilient. | Behavioural | CBT Curriculum - First Cohort, CBT Curriculum - Second Cohort (Waitlist Controls) |
Primary outcome
Composite of Self-Reported Suicidal Ideation and Attempts
Time frame: Approximately 1-year period of study
Composite includes self-reported suicidal ideation and self-reported suicide attempts, assessed by questions in the Life Problems Inventory (LPI).
6 secondary outcomes
Presentation of Self-harm and Suicide Attempts
Time frame: 1-year period of study
Revised Children's Anxiety and Depression Scale
Time frame: Approximately 1-year period of study
Life Problems Inventory Questionnaire
Time frame: Approximately 1-year period of study
Coping Scale for Children and Youth Questionnaire
Time frame: Approximately 1-year period of study
Student Satisfaction Questionnaire and Focus Group
Time frame: Approximately 1-year period of study
Teacher Satisfaction Questionnaire and Focus Group
Time frame: Approximately 1-year period of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Website for the MyOwl website which contains all the lesson plans and student activities for the curriculum.Link provided by the sponsor.
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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.
1 site 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 Curriculum in people with Suicidal Ideation and Suicidal and Self-injurious Behavior, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Jul 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Sinyor, MD (416-480-4070, mark.sinyor@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Self-Reported Suicidal Ideation and Attempts (time frame: Approximately 1-year period of study). 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 25 Jul 2024.