Major Depressive DisorderNCT05694156
Musical Attention Control and Executive Function Training for Adults With MDD
A study testing Music-based cognitive training in people with Major Depressive Disorder and Cognitive Dysfunction, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The investigators have developed music-based cognitive training sessions derived from Neurologic Music Therapy (NMT) techniques. The music-based cognitive training sessions will address areas of attention and executive function, which appear to progress over time and worsen as an individual experiences more episodes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder, Cognitive Dysfunction, Suicide
- What is being tested?
- Music-based cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2023to 2 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MDD meeting the Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-V) criteria
- Experiencing suicidal ideation in the past week (Beck Scale for Suicide Ideation >10)
- Have received more than 12 sessions of psychotherapy
- Stable medication use > 4 weeks
- Ability to undergo music-based cognitive training sessions in English
- Capable of giving informed consent
Who cannot join
- The presence of cognitive impairment that would limit consent or understanding of neurologic music therapy
- The presence of active psychosis
- The presence of mood and suicidal symptom severity requiring immediate treatment
- Hearing impairment
- Participation in music therapy 6 months prior to study
- Private music lessons for a period of 1 year prior to study
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The investigators have developed music-based cognitive training sessions derived from Neurologic Music Therapy (NMT) techniques. The music-based cognitive training sessions will address areas of attention and executive function, which appear to progress over time and worsen as an individual experiences more episodes of depression. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with major depressive disorder.
Read the detailed description
Major Depressive Disorder (MDD) is a lifelong condition and is the leading cause of disability in the world. MDD is a multifaceted mood disorder and due to its complex nature, this mental health diagnosis affects emotional, behavioural, and cognitive processing. Cognitive dysfunction appears to progress over time and worsens as the individual experiences more episodes of depression. Because of this, it is critical to continue to investigate and formulate effective treatment that can target and improve not only depressive symptoms, but also address overall cognitive function. Thus, the investigators propose implementing music-based cognitive training derived from Neurologic Music Therapy (NMT) techniques to address cognitive dysfunction experienced by adults diagnosed with MDD. Music-based interventions, specifically from the NMT approach have been shown to physically change the human brain when working on cognition in areas of attention and executive function, however little is known of these applications with adults with MDD. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with MDD.
- Conditions
- Major Depressive Disorder, Cognitive Dysfunction, Suicide
- Being tested
- Music-based cognitive training
- Keywords
- music-based intervention, cognition, depression
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-based cognitive trainingOther
8-week music-based cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Music-based cognitive training | Experimental | Music-based cognitive training sessions are derived from two Neurologic Music Therapy techniques: Musical Attention Control Training (MACT) and Musical Executive Function Training (MEFT). MACT exercises will focus on sustained and selective attention to emphasise flexibility and adaptability of the auditory attention system. MEFT exercises will provide opportunity for decision making, problem solving, reasoning, comprehending, organising, initiating, inhibiting, evaluating, analysing, and creating. Receives: Other: Music-based cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inhibition using the Go/No Go Task
This cognitive task measures response time, accuracy, commission errors, omission errors, and reaction time variability.
Measured: From baseline to 8-weeks
Change in working memory capacity using the Digit Span Forward and Backward Test
This cognitive task measures span length, correct recall, error rate, and reaction time.
Measured: From baseline to 8-weeks
Change in cognitive flexibility and executive control using the Shifting Attention test
This cognitive task measures the ability to shift attention between different stimuli, assessing the speed and accuracy with which the individual can shift their attention and switch between different rules.
Measured: From baseline to 8-weeks
Change in visual attention and task switching using the Trail Making A and B test
This cognitive task measures the time to complete the task and errors made.
In Trail Making Test A, a longer completion time and higher number of errors can indicate difficulties with processing speed and attention.
In Trail Making Test B, a longer completion time and a higher number of errors on Trail Making Test B, compared to Trail Making Test A, can indicate difficulties with cognitive flexibility, mental shifting, and attention.
Measured: From baseline to 8-weeks
Change in selective attention using the Stroop Test
This cognitive task measures the time to complete the task and errors made. A longer completion time and a higher number of errors can indicate difficulty with selective attention and mental flexibility.
Measured: From baseline to 8-weeks
Secondary outcomes (5)
Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)
A 21-item self-report scale that quantifies suicidal ideation. The BSSI is a Likert-style questionnaire, where each item is rated on a scale from 0 to 3, with higher scores indicating a greater severity of suicidal thoughts and behaviours. The minimum possible score on the BSSI is 0, which would indicate the absence of suicidal ideation. The maximum possible score is 63, which would indicate a high level of severity of suicidal thoughts and behaviours.
Measured: From baseline to 8-weeks
Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)
A 10-item scale to assess the experience of positive and negative emotions/feelings. Each item is rated on a 5-point Likert scale, ranging from 1 (very slightly or not at all) to 5 (extremely).
The minimum possible score on the PNAS-SF for positive affect is 10, which would indicate the absence of positive affect. The maximum possible score is 50, which would indicate a high level of positive affect.
The minimum possible score on the PNAS-SF for negative affect is 10, which would indicate the absence of negative affect. The maximum possible score is 50, which would indicate a high level of negative affect.
Measured: From baseline to 8-weeks
Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).
A 16-item validated depression scale. Each item is rated on a 4-point Likert scale, ranging from 0 (not at all) to 3 (severe).
The minimum possible score on the QID-SR is 0, which would indicate the absence of depression. The maximum possible score is 48, which would indicate a high level of depression severity.
Measured: From baseline to 8-weeks
Changes in quality of life using the Quality of Life Scale (QOLS)
A validated 16-item scale to assess quality of life. Each item is rated on a 7-point Likert scale , ranging from 1 (terrible) to 7 (delighted).
The minimum possible score on the QOLS is 16, which would indicate poor quality of life. The maximum possible score is 112, which would indicate excellent quality of life.
Measured: From baseline to 8-weeks
Feasibility and acceptability of music-based cognitive training
Feasibility and Acceptability survey and interview created in-house with questions designed to collect quantitative and qualitative feedback from participants with respect to the feasibility and acceptability of the music-based cognitive training intervention.
Measured: From baseline to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start17 Aug 2023
- Primary completion2 May 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sakina Rizvi, PhD,MACP,RP, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694156
- Sponsor's protocol ID
- MBCT-01
- Status last verified
- Feb 2025
- First submitted
- 27 Dec 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baune BT, Air T. Clinical, Functional, and Biological Correlates of Cognitive Dimensions in Major Depressive Disorder - Rationale, Design, and Characteristics of the Cognitive Function and Mood Study (CoFaM-Study). Front Psychiatry. 2016 Aug 26;7:150. doi: 10.3389/fpsyt.2016.00150. eCollection 2016.
PubMed 27616997Pan Z, Park C, Brietzke E, Zuckerman H, Rong C, Mansur RB, Fus D, Subramaniapillai M, Lee Y, McIntyre RS. Cognitive impairment in major depressive disorder. CNS Spectr. 2019 Feb;24(1):22-29. doi: 10.1017/S1092852918001207. Epub 2018 Nov 23.
PubMed 30468135McIntyre RS, Soczynska JZ, Woldeyohannes HO, Alsuwaidan MT, Cha DS, Carvalho AF, Jerrell JM, Dale RM, Gallaugher LA, Muzina DJ, Kennedy SH. The impact of cognitive impairment on perceived workforce performance: results from the International Mood Disorders Collaborative Project. Compr Psychiatry. 2015 Jan;56:279-82. doi: 10.1016/j.comppsych.2014.08.051. Epub 2014 Aug 23.
PubMed 25439523Thaut MH, Gardiner JC, Holmberg D, Horwitz J, Kent L, Andrews G, Donelan B, McIntosh GR. Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Ann N Y Acad Sci. 2009 Jul;1169:406-16. doi: 10.1111/j.1749-6632.2009.04585.x.
PubMed 19673815Hsu WC, Lai HL. Effects of music on major depression in psychiatric inpatients. Arch Psychiatr Nurs. 2004 Oct;18(5):193-9. doi: 10.1016/j.apnu.2004.07.007.
PubMed 15529285Keilp JG, Gorlyn M, Russell M, Oquendo MA, Burke AK, Harkavy-Friedman J, Mann JJ. Neuropsychological function and suicidal behavior: attention control, memory and executive dysfunction in suicide attempt. Psychol Med. 2013 Mar;43(3):539-51. doi: 10.1017/S0033291712001419. Epub 2012 Jul 10.
PubMed 22781400Lam RW, Kennedy SH, Mclntyre RS, Khullar A. Cognitive dysfunction in major depressive disorder: effects on psychosocial functioning and implications for treatment. Can J Psychiatry. 2014 Dec;59(12):649-54. doi: 10.1177/070674371405901206. No abstract available.
PubMed 25702365Strait DL, Kraus N. Can you hear me now? Musical training shapes functional brain networks for selective auditory attention and hearing speech in noise. Front Psychol. 2011 Jun 13;2:113. doi: 10.3389/fpsyg.2011.00113. eCollection 2011.
PubMed 21716636Strait DL, Slater J, O'Connell S, Kraus N. Music training relates to the development of neural mechanisms of selective auditory attention. Dev Cogn Neurosci. 2015 Apr;12:94-104. doi: 10.1016/j.dcn.2015.01.001. Epub 2015 Jan 13.
PubMed 25660985Thaut MH, McIntosh GC, Hoemberg V. Neurobiological foundations of neurologic music therapy: rhythmic entrainment and the motor system. Front Psychol. 2015 Feb 18;5:1185. doi: 10.3389/fpsyg.2014.01185. eCollection 2014.
PubMed 25774137Zatorre RJ. Musical pleasure and reward: mechanisms and dysfunction. Ann N Y Acad Sci. 2015 Mar;1337:202-11. doi: 10.1111/nyas.12677.
PubMed 25773636Culpepper L, Lam RW, McIntyre RS. Cognitive Impairment in Patients With Depression: Awareness, Assessment, and Management. J Clin Psychiatry. 2017 Nov/Dec;78(9):1383-1394. doi: 10.4088/JCP.tk16043ah5c.
PubMed 29345866Knight MJ, Baune BT. Executive Subdomains Are Differentially Associated With Psychosocial Outcomes in Major Depressive Disorder. Front Psychiatry. 2018 Jul 10;9:309. doi: 10.3389/fpsyt.2018.00309. eCollection 2018.
PubMed 30042703
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Attention Control and Executive Function Training for Adults With MDD
- ClinicalTrials.gov ID
- NCT05694156
- Acronym / sponsor ID
- MBCT-01
- Conditions
- Major Depressive Disorder, Cognitive Dysfunction, Suicide
- Keywords
- music-based intervention, cognition, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 23 Jan 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 investigators have developed music-based cognitive training sessions derived from Neurologic Music Therapy (NMT) techniques. The music-based cognitive training sessions will address areas of attention and executive function, which appear to progress over time and worsen as an individual experiences more episodes of depression. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with major depressive disorder.
Detailed description
Major Depressive Disorder (MDD) is a lifelong condition and is the leading cause of disability in the world. MDD is a multifaceted mood disorder and due to its complex nature, this mental health diagnosis affects emotional, behavioural, and cognitive processing. Cognitive dysfunction appears to progress over time and worsens as the individual experiences more episodes of depression. Because of this, it is critical to continue to investigate and formulate effective treatment that can target and improve not only depressive symptoms, but also address overall cognitive function. Thus, the investigators propose implementing music-based cognitive training derived from Neurologic Music Therapy (NMT) techniques to address cognitive dysfunction experienced by adults diagnosed with MDD. Music-based interventions, specifically from the NMT approach have been shown to physically change the human brain when working on cognition in areas of attention and executive function, however little is known of these applications with adults with MDD. The aim of this pilot is to test 8-weeks of music-based cognitive training to improve cognitive function among adults with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music-based cognitive training | Experimental | Other: Music-based cognitive trainingMusic-based cognitive training sessions are derived from two Neurologic Music Therapy techniques: Musical Attention Control Training (MACT) and Musical Executive Function Training (MEFT). MACT exercises will focus on sustained and selective attention to emphasise flexibility and adaptability of the auditory attention system. MEFT exercises will provide opportunity for decision making, problem solving, reasoning, comprehending, organising, initiating, inhibiting, evaluating, analysing, and creating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of MDD meeting the Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-V) criteria
- Experiencing suicidal ideation in the past week (Beck Scale for Suicide Ideation >10)
- Have received more than 12 sessions of psychotherapy
- Stable medication use > 4 weeks
- Ability to undergo music-based cognitive training sessions in English
Key exclusion criteria (7 listed)
- The presence of cognitive impairment that would limit consent or understanding of neurologic music therapy
- The presence of active psychosis
- The presence of mood and suicidal symptom severity requiring immediate treatment
- Hearing impairment
- Participation in music therapy 6 months prior to study
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 |
|---|---|---|
| Music-based cognitive training8-week music-based cognitive training | Other | Music-based cognitive training |
Primary outcome
Change in inhibition using the Go/No Go Task
Time frame: From baseline to 8-weeks
This cognitive task measures response time, accuracy, commission errors, omission errors, and reaction time variability.
Change in working memory capacity using the Digit Span Forward and Backward Test
Time frame: From baseline to 8-weeks
This cognitive task measures span length, correct recall, error rate, and reaction time.
Change in cognitive flexibility and executive control using the Shifting Attention test
Time frame: From baseline to 8-weeks
This cognitive task measures the ability to shift attention between different stimuli, assessing the speed and accuracy with which the individual can shift their attention and switch between different rules.
Change in visual attention and task switching using the Trail Making A and B test
Time frame: From baseline to 8-weeks
This cognitive task measures the time to complete the task and errors made. In Trail Making Test A, a longer completion time and higher number of errors can indicate difficulties with processing speed and attention. In Trail Making Test B, a longer completion time and a higher number of errors on Trail Making Test B, compared to Trail Making Test A, can indicate difficulties with cognitive flexibility, mental shifting, and attention.
Change in selective attention using the Stroop Test
Time frame: From baseline to 8-weeks
This cognitive task measures the time to complete the task and errors made. A longer completion time and a higher number of errors can indicate difficulty with selective attention and mental flexibility.
5 secondary outcomes
Change in suicidal ideation using the Beck Scale for Suicide Ideation (BSSI)
Time frame: From baseline to 8-weeks
Changes in affect using the Positive and negative affect schedule - short form (PNAS-SF)
Time frame: From baseline to 8-weeks
Changes in depression symptoms using the Quick Inventory of Depressive Symptomatology - self-report (QIDS-SR).
Time frame: From baseline to 8-weeks
Changes in quality of life using the Quality of Life Scale (QOLS)
Time frame: From baseline to 8-weeks
Feasibility and acceptability of music-based cognitive training
Time frame: From baseline to 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Background: PubMed 27616997Baune BT, Air T. Clinical, Functional, and Biological Correlates of Cognitive Dimensions in Major Depressive Disorder - Rationale, Design, and Characteristics of the Cognitive Function and Mood Study (CoFaM-Study). Front Psychiatry. 2016 Aug 26;7:150. doi: 10.3389/fpsyt.2016.00150. eCollection 2016.
- Background: PubMed 30468135Pan Z, Park C, Brietzke E, Zuckerman H, Rong C, Mansur RB, Fus D, Subramaniapillai M, Lee Y, McIntyre RS. Cognitive impairment in major depressive disorder. CNS Spectr. 2019 Feb;24(1):22-29. doi: 10.1017/S1092852918001207. Epub 2018 Nov 23.
- Background: PubMed 25439523McIntyre RS, Soczynska JZ, Woldeyohannes HO, Alsuwaidan MT, Cha DS, Carvalho AF, Jerrell JM, Dale RM, Gallaugher LA, Muzina DJ, Kennedy SH. The impact of cognitive impairment on perceived workforce performance: results from the International Mood Disorders Collaborative Project. Compr Psychiatry. 2015 Jan;56:279-82. doi: 10.1016/j.comppsych.2014.08.051. Epub 2014 Aug 23.
- Background: PubMed 19673815Thaut MH, Gardiner JC, Holmberg D, Horwitz J, Kent L, Andrews G, Donelan B, McIntosh GR. Neurologic music therapy improves executive function and emotional adjustment in traumatic brain injury rehabilitation. Ann N Y Acad Sci. 2009 Jul;1169:406-16. doi: 10.1111/j.1749-6632.2009.04585.x.
- Background: PubMed 15529285Hsu WC, Lai HL. Effects of music on major depression in psychiatric inpatients. Arch Psychiatr Nurs. 2004 Oct;18(5):193-9. doi: 10.1016/j.apnu.2004.07.007.
- Background: PubMed 22781400Keilp JG, Gorlyn M, Russell M, Oquendo MA, Burke AK, Harkavy-Friedman J, Mann JJ. Neuropsychological function and suicidal behavior: attention control, memory and executive dysfunction in suicide attempt. Psychol Med. 2013 Mar;43(3):539-51. doi: 10.1017/S0033291712001419. Epub 2012 Jul 10.
- Background: PubMed 25702365Lam RW, Kennedy SH, Mclntyre RS, Khullar A. Cognitive dysfunction in major depressive disorder: effects on psychosocial functioning and implications for treatment. Can J Psychiatry. 2014 Dec;59(12):649-54. doi: 10.1177/070674371405901206. No abstract available.
- Background: PubMed 21716636Strait DL, Kraus N. Can you hear me now? Musical training shapes functional brain networks for selective auditory attention and hearing speech in noise. Front Psychol. 2011 Jun 13;2:113. doi: 10.3389/fpsyg.2011.00113. eCollection 2011.
- Background: PubMed 25660985Strait DL, Slater J, O'Connell S, Kraus N. Music training relates to the development of neural mechanisms of selective auditory attention. Dev Cogn Neurosci. 2015 Apr;12:94-104. doi: 10.1016/j.dcn.2015.01.001. Epub 2015 Jan 13.
- Background: PubMed 25774137Thaut MH, McIntosh GC, Hoemberg V. Neurobiological foundations of neurologic music therapy: rhythmic entrainment and the motor system. Front Psychol. 2015 Feb 18;5:1185. doi: 10.3389/fpsyg.2014.01185. eCollection 2014.
- Background: PubMed 25773636Zatorre RJ. Musical pleasure and reward: mechanisms and dysfunction. Ann N Y Acad Sci. 2015 Mar;1337:202-11. doi: 10.1111/nyas.12677.
- Background: PubMed 29345866Culpepper L, Lam RW, McIntyre RS. Cognitive Impairment in Patients With Depression: Awareness, Assessment, and Management. J Clin Psychiatry. 2017 Nov/Dec;78(9):1383-1394. doi: 10.4088/JCP.tk16043ah5c.
- 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.
Sakina Rizvi, PhD,MACP,RP principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-based cognitive training in people with Major Depressive Disorder and Cognitive Dysfunction, run by Unity Health Toronto 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 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inhibition using the Go/No Go Task (time frame: From baseline to 8-weeks). The study lists 5 primary outcomes in all. 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 NCT05694156, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.