Depression, AnxietyNCT05455905
Voice Biomarkers Predictive of Depression and Anxiety
An observational study of Depression, Anxiety and Healthy, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.
Trial summary
The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety, Healthy, Mental Health Wellness 1
- What is being tested?
- Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Hamilton Depression Rating Scale
- How many people
- 19,533 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2021to 11 Sep 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population will include males and females fluent in English over the age of 18 in the United States and Canada. Participants both with and without a personal history of depression and/or anxiety are eligible to participate in the study. Participants will require access to a laptop, smartphone, or tablet with a functioning microphone and provide stated willingness to comply with all study procedures and availability for the duration of the study. Participants with a visual or motor impairment that would make it difficult to use the web-based survey will be excluded from the study.
Who may be able to join
- Adult males and or females over the age of 18 at the time of informed consent. Adults with a known history of depression and/or anxiety and adults without a known history of depression and/or anxiety will be included in this study.
- Access to a laptop, smart-phone or tablet with a functioning microphone
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Fluency in English
Who cannot join
- Visual impairment that would make it difficult for the participant to see the web-based survey
- Motor impairment that would make it difficult for the participant to use the web-based survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Kintsugi Mindful Wellness, Inc.
Berkeley, California, 94705
About this study
Official title: Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study
The objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.
Read the detailed description
Participants will be recruited via various online mediums to participate in a voluntary observational study. Completing the consent and survey on their smart-phone, tablet, or computer, the participant will be asked to provide a 1-minute response to an audio prompt "How was your day?" After recording their response, the participant will be asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 measures independently.
In a second voluntary phase of the study, participants who indicated a score higher than 20, will be contacted by the research team via email to determine if they are interested in a voluntary follow-up to their initial study participation. Participants who would like to take part in the additional survey will complete additional voice recording responses to prompts and complete the Patient History Questionnaire and Generalized Anxiety Disorder-7. These participants will be contacted by a Mental Health Professional to discuss seeking mental health resources and clinicians, as well as, complete the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale via the telephone.
- Conditions
- Depression, Anxiety, Healthy, Mental Health Wellness 1
- Being tested
- Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale
- Keywords
- mental health, depression, anxiety, Artificial Intelligence
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Health Questionnaire-9Diagnostic test
Also called PHQ-9
The Patient Health Questionnaire-9 is a nine question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Patient Health Questionnaire-9 is scored from 0 to 27 where higher scores are associated with more severe depression.
Generalized Anxiety Disorder-7Diagnostic test
Also called GAD-7
The Generalized Anxiety Disorder-7 is a seven question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Generalized Anxiety Disorder-7 is scored from 0 to 21 where higher scores are associated with more severe anxiety.
Hamilton Depression Rating ScaleDiagnostic test
Also called HDRS, HAM-D
The Hamilton Depression Rating Scale is administered by a mental health profession and includes twenty-one questions asking about how the participant has been feeling in the past week. The Hamilton Depression Rating Scale is scored from 0 to 45 where higher scores are associated with more severe depression.
Hamilton Anxiety Rating ScaleDiagnostic test
Also called HARS, HAM-A
The Hamilton Anxiety Rating Scale is administered by a mental health profession and includes fourteen questions asking about how the participant has been feeling in the past week. The Hamilton Anxiety Rating Scale is scored from 0 to 56 where higher scores are associated with more severe anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Main Study Cohort | A web-based audio recording tool will be used to record voice sample answering the prompt, "How are you feeling today?" Participants are asked to speak for 1-minute. Following the recording, participants are asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questions. Receives: Diagnostic Test: Patient Health Questionnaire-9; Diagnostic Test: Generalized Anxiety Disorder-7 | |
| Selected Self-Reported Depression Cohort | The Researcher will review Patient Health Questionnaire-9 scores of all the participants and select the subset that self-reported a scored greater than 20, on a scale from 0 to 27. Participants will be approached via email to complete an additional administration of the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaires and be offered resources for depression and anxiety and how to set up an appointment with a mental health professional. Receives: Diagnostic Test: Patient Health Questionnaire-9; Diagnostic Test: Generalized Anxiety Disorder-7; Diagnostic Test: Hamilton Depression Rating Scale; Diagnostic Test: Hamilton Anxiety Rating Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Participants will be interviewed by mental health professionals using the clinically validated Hamilton Depression Rating Scale, which has a score range of 0 to 54, where higher scores are associated with higher severity of depression.
Measured: Through study completion, on average 12months
Hamilton Anxiety Rating Scale
Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety.
Measured: Through study completion, on average 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start14 Sep 2021
- Primary completion11 Sep 2022
- Study completion11 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 19,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mei-Hsin Cheng, PhD, Principal investigator, Kintsugi Mindful Wellness, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455905
- Sponsor's protocol ID
- 2021/08/25
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
PubMed 32790653ADAA. Facts & statistics: Anxiety and Depression Association of America. Retrieved March 05, 2021, from https://adaa.org/about-adaa/press-room/facts-statistics
Low DM, Bentley KH, Ghosh SS. Automated assessment of psychiatric disorders using speech: A systematic review. Laryngoscope Investig Otolaryngol. 2020 Jan 31;5(1):96-116. doi: 10.1002/lio2.354. eCollection 2020 Feb.
PubMed 32128436Mundt JC, Vogel AP, Feltner DE, Lenderking WR. Vocal acoustic biomarkers of depression severity and treatment response. Biol Psychiatry. 2012 Oct 1;72(7):580-7. doi: 10.1016/j.biopsych.2012.03.015. Epub 2012 Apr 26.
PubMed 22541039Zhang L, Duvvuri R, Chandra KKL, Nguyen T, Ghomi RH. Automated voice biomarkers for depression symptoms using an online cross-sectional data collection initiative. Depress Anxiety. 2020 Jul;37(7):657-669. doi: 10.1002/da.23020. Epub 2020 May 7.
PubMed 32383335Espinola, CW, Gomes, JC, Pereira, JMS et. al. Detection of major depressive disorder using vocal acoustic analysis and machine learning-an exploratory study. Res. Biomed. Eng. 2021; 37: 53-64.
Wang J, Zhang L, Liu T, Pan W, Hu B, Zhu T. Acoustic differences between healthy and depressed people: a cross-situation study. BMC Psychiatry. 2019 Oct 15;19(1):300. doi: 10.1186/s12888-019-2300-7.
PubMed 31615470He L, Cao C. Automated depression analysis using convolutional neural networks from speech. J Biomed Inform. 2018 Jul;83:103-111. doi: 10.1016/j.jbi.2018.05.007. Epub 2018 May 29.
PubMed 29852317Ozkanca Y, Ozturk MG, Ekmekci MN, Atkins DC, Demiroglu C, Ghomi RH. Depression Screening from Voice Samples of Patients Affected by Parkinson's Disease. Digit Biomark. 2019 May-Aug;3(2):72-82. doi: 10.1159/000500354. Epub 2019 Jun 12.
PubMed 31872172Yi H, Smiljanic R, Chandrasekaran B. The Effect of Talker and Listener Depressive Symptoms on Speech Intelligibility. J Speech Lang Hear Res. 2019 Nov 18;62(12):4269-4281. doi: 10.1044/2019_JSLHR-S-19-0112. Print 2019 Dec 18.
PubMed 31738862Stassen HH, Bomben G, Gunther E. Speech characteristics in depression. Psychopathology. 1991;24(2):88-105. doi: 10.1159/000284700.
PubMed 1886971Taguchi T, Tachikawa H, Nemoto K, Suzuki M, Nagano T, Tachibana R, Nishimura M, Arai T. Major depressive disorder discrimination using vocal acoustic features. J Affect Disord. 2018 Jan 1;225:214-220. doi: 10.1016/j.jad.2017.08.038. Epub 2017 Aug 16.
PubMed 28841483Low LS, Maddage NC, Lech M, Sheeber LB, Allen NB. Detection of clinical depression in adolescents' speech during family interactions. IEEE Trans Biomed Eng. 2011 Mar;58(3):574-86. doi: 10.1109/TBME.2010.2091640. Epub 2010 Nov 11.
PubMed 21075715Tuka A, Mohammad G, and James G. Detecting Depression with Audio/Text Sequence Modeling of Interviews. Interspeech. 2018; 2522.
Pan W, Flint J, Shenhav L, Liu T, Liu M, Hu B, Zhu T. Re-examining the robustness of voice features in predicting depression: Compared with baseline of confounders. PLoS One. 2019 Jun 20;14(6):e0218172. doi: 10.1371/journal.pone.0218172. eCollection 2019.
PubMed 31220113
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Biomarkers Predictive of Depression and Anxiety: An Observational Study
- ClinicalTrials.gov ID
- NCT05455905
- Acronym / sponsor ID
- 2021/08/25
- Conditions
- Depression, Anxiety, Healthy, Mental Health Wellness 1
- Keywords
- mental health, depression, anxiety, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,533 participants (actual)
- Lead sponsor
- Kintsugi Mindful Wellness, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 11 Sep 2022 (actual)
- Study completion
- 11 Sep 2022 (actual)
- First posted
- 13 Jul 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 objective of this study is to collect data to improve the sensitivity and specificity of Kintsugi Voice's (formerly KiVATM) predictions on audio files. A web-based audio recording tool will be used to record voice sample and ask participants the PHQ-9 and GAD-7 questions. A voluntary subset of participants will then be assessed by mental health professionals with the Hamilton Depression Rating Scale (HAM-D) and Hamilton Anxiety Rating Scale (HAM-A) scores.
Detailed description
Participants will be recruited via various online mediums to participate in a voluntary observational study. Completing the consent and survey on their smart-phone, tablet, or computer, the participant will be asked to provide a 1-minute response to an audio prompt "How was your day?" After recording their response, the participant will be asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 measures independently.
In a second voluntary phase of the study, participants who indicated a score higher than 20, will be contacted by the research team via email to determine if they are interested in a voluntary follow-up to their initial study participation. Participants who would like to take part in the additional survey will complete additional voice recording responses to prompts and complete the Patient History Questionnaire and Generalized Anxiety Disorder-7. These participants will be contacted by a Mental Health Professional to discuss seeking mental health resources and clinicians, as well as, complete the Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale via the telephone.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main Study Cohort | – | Diagnostic Test: Patient Health Questionnaire-9, Diagnostic Test: Generalized Anxiety Disorder-7A web-based audio recording tool will be used to record voice sample answering the prompt, "How are you feeling today?" Participants are asked to speak for 1-minute. Following the recording, participants are asked to complete the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questions. |
| Selected Self-Reported Depression Cohort | – | Diagnostic Test: Patient Health Questionnaire-9, Diagnostic Test: Generalized Anxiety Disorder-7, Diagnostic Test: Hamilton Depression Rating Scale, Diagnostic Test: Hamilton Anxiety Rating ScaleThe Researcher will review Patient Health Questionnaire-9 scores of all the participants and select the subset that self-reported a scored greater than 20, on a scale from 0 to 27. Participants will be approached via email to complete an additional administration of the Patient Health Questionnaire-9 and Generalized Anxiety Disorder-7 questionnaires and be offered resources for depression and anxiety and how to set up an appointment with a mental health professional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include males and females fluent in English over the age of 18 in the United States and Canada. Participants both with and without a personal history of depression and/or anxiety are eligible to participate in the study. Participants will require access to a laptop, smartphone, or tablet with a functioning microphone and provide stated willingness to comply with all study procedures and availability for the duration of the study. Participants with a visual or motor impairment that would make it difficult to use the web-based survey will be excluded from the study.
Key inclusion criteria (4 listed)
- Adult males and or females over the age of 18 at the time of informed consent. Adults with a known history of depression and/or anxiety and adults without a known history of depression and/or anxiety will be included in this study.
- Access to a laptop, smart-phone or tablet with a functioning microphone
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Fluency in English
Key exclusion criteria (2 listed)
- Visual impairment that would make it difficult for the participant to see the web-based survey
- Motor impairment that would make it difficult for the participant to use the web-based survey
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 |
|---|---|---|
| Patient Health Questionnaire-9Also: PHQ-9The Patient Health Questionnaire-9 is a nine question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Patient Health Questionnaire-9 is scored from 0 to 27 where higher scores are associated with more severe depression. | Diagnostic test | Main Study Cohort, Selected Self-Reported Depression Cohort |
| Generalized Anxiety Disorder-7Also: GAD-7The Generalized Anxiety Disorder-7 is a seven question self-administered examination in which the patient indicates how often they have experienced different feelings and sensations in the past two weeks. The Generalized Anxiety Disorder-7 is scored from 0 to 21 where higher scores are associated with more severe anxiety. | Diagnostic test | Main Study Cohort, Selected Self-Reported Depression Cohort |
| Hamilton Depression Rating ScaleAlso: HDRS, HAM-DThe Hamilton Depression Rating Scale is administered by a mental health profession and includes twenty-one questions asking about how the participant has been feeling in the past week. The Hamilton Depression Rating Scale is scored from 0 to 45 where higher scores are associated with more severe depression. | Diagnostic test | Selected Self-Reported Depression Cohort |
| Hamilton Anxiety Rating ScaleAlso: HARS, HAM-AThe Hamilton Anxiety Rating Scale is administered by a mental health profession and includes fourteen questions asking about how the participant has been feeling in the past week. The Hamilton Anxiety Rating Scale is scored from 0 to 56 where higher scores are associated with more severe anxiety. | Diagnostic test | Selected Self-Reported Depression Cohort |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Through study completion, on average 12months
Participants will be interviewed by mental health professionals using the clinically validated Hamilton Depression Rating Scale, which has a score range of 0 to 54, where higher scores are associated with higher severity of depression.
Hamilton Anxiety Rating Scale
Time frame: Through study completion, on average 12 months
Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety.
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 15 Sep 2022.
- Background: PubMed 32790653Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.
- BackgroundADAA. Facts & statistics: Anxiety and Depression Association of America. Retrieved March 05, 2021, from https://adaa.org/about-adaa/press-room/facts-statistics
- Background: PubMed 32128436Low DM, Bentley KH, Ghosh SS. Automated assessment of psychiatric disorders using speech: A systematic review. Laryngoscope Investig Otolaryngol. 2020 Jan 31;5(1):96-116. doi: 10.1002/lio2.354. eCollection 2020 Feb.
- Background: PubMed 22541039Mundt JC, Vogel AP, Feltner DE, Lenderking WR. Vocal acoustic biomarkers of depression severity and treatment response. Biol Psychiatry. 2012 Oct 1;72(7):580-7. doi: 10.1016/j.biopsych.2012.03.015. Epub 2012 Apr 26.
- Background: PubMed 32383335Zhang L, Duvvuri R, Chandra KKL, Nguyen T, Ghomi RH. Automated voice biomarkers for depression symptoms using an online cross-sectional data collection initiative. Depress Anxiety. 2020 Jul;37(7):657-669. doi: 10.1002/da.23020. Epub 2020 May 7.
- BackgroundEspinola, CW, Gomes, JC, Pereira, JMS et. al. Detection of major depressive disorder using vocal acoustic analysis and machine learning-an exploratory study. Res. Biomed. Eng. 2021; 37: 53-64.
- Background: PubMed 31615470Wang J, Zhang L, Liu T, Pan W, Hu B, Zhu T. Acoustic differences between healthy and depressed people: a cross-situation study. BMC Psychiatry. 2019 Oct 15;19(1):300. doi: 10.1186/s12888-019-2300-7.
- Background: PubMed 29852317He L, Cao C. Automated depression analysis using convolutional neural networks from speech. J Biomed Inform. 2018 Jul;83:103-111. doi: 10.1016/j.jbi.2018.05.007. Epub 2018 May 29.
- Background: PubMed 31872172Ozkanca Y, Ozturk MG, Ekmekci MN, Atkins DC, Demiroglu C, Ghomi RH. Depression Screening from Voice Samples of Patients Affected by Parkinson's Disease. Digit Biomark. 2019 May-Aug;3(2):72-82. doi: 10.1159/000500354. Epub 2019 Jun 12.
- Background: PubMed 31738862Yi H, Smiljanic R, Chandrasekaran B. The Effect of Talker and Listener Depressive Symptoms on Speech Intelligibility. J Speech Lang Hear Res. 2019 Nov 18;62(12):4269-4281. doi: 10.1044/2019_JSLHR-S-19-0112. Print 2019 Dec 18.
- Background: PubMed 1886971Stassen HH, Bomben G, Gunther E. Speech characteristics in depression. Psychopathology. 1991;24(2):88-105. doi: 10.1159/000284700.
- Background: PubMed 28841483Taguchi T, Tachikawa H, Nemoto K, Suzuki M, Nagano T, Tachibana R, Nishimura M, Arai T. Major depressive disorder discrimination using vocal acoustic features. J Affect Disord. 2018 Jan 1;225:214-220. doi: 10.1016/j.jad.2017.08.038. Epub 2017 Aug 16.
- 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.
Mei-Hsin Cheng, PhD principal investigator
Kintsugi Mindful Wellness, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, Anxiety and Healthy, run by Kintsugi Mindful Wellness, Inc. at 1 site in United States.
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 4 inclusion and 2 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 15 Sep 2022. 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 United States. 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?
Hamilton Depression Rating Scale (time frame: Through study completion, on average 12months). The study lists 2 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 NCT05455905, which also lists 21 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 15 Sep 2022.