ECTCoEffECTNCT03490149
Prediction of the Cognitive Effects of Electroconvulsive Therapy Via Machine Learning and Neuroimaging
An observational study of ECT and Depression, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
The study aims to use machine learning to predict the occurrence of episodic and autobiographical memory deficits as well as treatment response following a course of electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive effects after a course of ECT will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ECT, Depression, Cognitive Impairment
- What is being tested?
- Electroconvulsive Therapy and Medication - Treatment as usual
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2018to 1 Dec 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Inpatients at the psychiatric hospital of the University Hospital Bonn. The patients diagnosis of major depressive disorder will be verified via the structured clinical interview for DSM-5. ECT protocol in line with international standards administered by a staff psychiatrist. Additionally, a medication-only and a healthy control sample are included in the study.
Who may be able to join
- The duration of the current depressive episode is at least four weeks
- The duration of the current depressive episode is less than five years
- Inpatients of the psychiatric clinic of the University Hospital Bonn and eligible for ECT because of major depressive disorder or major depressive episode in bipolar disorder (according to DSM-5 criteria)
- Score on HDRS 28 ≥ 20
- Ability to understand the purpose of and procedures required for the study and willingness to consent to participation
- Meeting of standard medical prerequisites for ECT (judged by staff psychiatrist)
- Ability to speak and understand the german language
Who cannot join
- No lifetime occurence of a personality disorder
- Current (or within the last year) posttraumatic stress disorder
- Schizophrenia or any other psychotic disorder except for psychotic depression
- Severe somatic or neurological condition (e.g. stroke)
- Head trauma resulting in unconsciousness for more than 5 minutes
- Pregnancy
Show all 11Show fewer
- Maintenance ECT or ECT received during the last 6 month
- Subjects who do not consent to be informed of incidental findings that could have healthcare implications
- Drug or alcohol dependence (<6 month before ECT)
- Is currently enrolled in a study with an investigational study drug
- Has any condition that, in the opinion of the investigator, would compromise the wellbeing of the subject or the study or prevent the subject from meeting or performing study requirements
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik und Poliklinik für Psychiatrie und Psychotherapie
Bonn, North Rhine-Westphalia, 53105
Maximilian Kiebs, M.Sc., 0228287 ext. 19710, m.kiebs@ukbonn.de
About this study
The study aims to use machine learning to predict the occurrence of episodic and autobiographical memory deficits as well as treatment response following a course of electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive effects after a course of ECT will be investigated.
Therefore, structural, resting-state and diffusion tensor images will be collected within one week before the first and after the last ECT treatment from severely depressed patients. Standard measures of cognitive function and specifically episodic as well as autobiographical memory will also be collected longitudinally and used for prediction. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression, 60 medication-only controls and 60 healthy controls.
Read the detailed description
Due to the immense disease burden of major depression and unsatisfactory response to standard pharmacological and psychological treatments, the need for treatment alternatives is evident. Electroconvulsive therapy (ECT) remains to be the most efficacious treatment known for treatment-resistant depression. However, although many studies show response rates above 70%, ECT can be considered vastly underused. Reasons contributing to this phenomenon may include stigma, regulatory restrictions, limited medical training, safety and side-effect concerns, or reluctance among professionals to recommend ECT. Most of these reasons have already been refuted or put into perspective by psychological and neuroscientific studies (e.g. ECT causes brain lesions) and most cognitive deficits related to the ECT course seem to fade after several weeks of discontinuation.
Still, in terms of the tolerability, memory disturbances remain the most problematic effect of ECT. Besides subjective reports from patients after a course of ECT, experimental studies have also found evidence of episodic and autobiographical memory impiarment attributable to ECT. The origins of these effects are still largely unknown and remain a goal for further research.
It has now been shown that structural T1 weighted MR-images can be used to predict the response to a course of ECT via machine learning. Therefore, this study aims to use machine learning to predict the occurrence of episodic and specifically autobiographical memory deficits arising within a course of electroconvulsive therapy based on MR-images collected within one week before the first ECT treatment from severely depressed patients. Additionally, the neurophysiological correlates of the cognitive effects modulated by a course of ECT will be investigated longitudinally through the use of structural, resting-state and diffusion tensor images. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression.
If successful, this line of research should lead to a better tolerability of ECT by aiding in the complex decision making process involved in prescribing ECT as well as the parameter setting within a treatment course (e.g. uni- vs. bilateral).
- Conditions
- ECT, Depression, Cognitive Impairment, Memory Impairment
- Being tested
- Electroconvulsive Therapy, Medication - Treatment as usual
- Keywords
- ECT, Electroconvulsive Therapy, Depression, Memory, Memory Impairment
- Medical subject headings
- Depression, Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyDevice
Series of electroconvulsive therapy for major depressive disorder
Medication - Treatment as usualDrug
Medication only sample - Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| ECT | Not described Receives: Device: Electroconvulsive Therapy | |
| Medication - Treatment as usual | Not described Receives: Drug: Medication - Treatment as usual | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in auditory verbal learning performance
Auditory Verbal Learning Test (AVLT)
Measured: Within one week before first and one week after last ECT
Change in autobiographical memory performance
Autobiographical Memory Interview (AMI-SF)
Measured: Within one week before first and one week after last ECT
Change in subjective memory impairment
Qualitative Interview
Measured: Within one week before first and one week after last ECT
Occurence of retrograde amnesia
Measured: Within the first week after last ECT
Secondary outcomes (2)
Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS 28).
Hamilton Depression Rating Scale (HDRS 28). Remission defined as Hamilton Depression Rating Scale-28 score of less than or equal to 9 after the ECT course. Response defined as min. -50% change in Hamilton Depression Rating Scale-28 score after ECT.
Measured: One week before first and one week after last ECT
Change in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Montgomery-Åsberg Depression Rating Scale (MADRS). Remission defined as Montgomery-Åsberg Depression Rating Scale score of less than or equal to 7 after the ECT course. Response defined as min. -50% change in Montgomery-Åsberg Depression Rating Scale score after ECT.
Measured: One week before first and one week after last ECT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start2 Jan 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ECTStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
- Investigators
- Rene Hurlemann, Prof., Study director, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490149
- Sponsor's protocol ID
- CoEffECT - Study
- Acronym
- CoEffECT
- Status last verified
- May 2022
- First submitted
- 29 Mar 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
PubMed 23993280Sinyor M, Schaffer A, Levitt A. The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review. Can J Psychiatry. 2010 Mar;55(3):126-35. doi: 10.1177/070674371005500303.
PubMed 20370962UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003 Mar 8;361(9360):799-808. doi: 10.1016/S0140-6736(03)12705-5.
PubMed 12642045Haq AU, Sitzmann AF, Goldman ML, Maixner DF, Mickey BJ. Response of depression to electroconvulsive therapy: a meta-analysis of clinical predictors. J Clin Psychiatry. 2015 Oct;76(10):1374-84. doi: 10.4088/JCP.14r09528.
PubMed 26528644Sackeim HA. Modern Electroconvulsive Therapy: Vastly Improved yet Greatly Underused. JAMA Psychiatry. 2017 Aug 1;74(8):779-780. doi: 10.1001/jamapsychiatry.2017.1670. No abstract available.
PubMed 28658461Slade EP, Jahn DR, Regenold WT, Case BG. Association of Electroconvulsive Therapy With Psychiatric Readmissions in US Hospitals. JAMA Psychiatry. 2017 Aug 1;74(8):798-804. doi: 10.1001/jamapsychiatry.2017.1378.
PubMed 28658489Aoki Y, Yamaguchi S, Ando S, Sasaki N, Bernick PJ, Akiyama T. The experience of electroconvulsive therapy and its impact on associated stigma: A meta-analysis. Int J Soc Psychiatry. 2016 Dec;62(8):708-718. doi: 10.1177/0020764016675379. Epub 2016 Oct 26.
PubMed 27798050Bailine S. Reimbursement and documentation issues in an ambulatory ECT program. J ECT. 1998 Dec;14(4):255-8.
PubMed 9871847Case BG, Bertollo DN, Laska EM, Price LH, Siegel CE, Olfson M, Marcus SC. Declining use of electroconvulsive therapy in United States general hospitals. Biol Psychiatry. 2013 Jan 15;73(2):119-26. doi: 10.1016/j.biopsych.2012.09.005. Epub 2012 Oct 8.
PubMed 23059049Wilhelmy S, Rolfes V, Grozinger M, Chikere Y, Schottle S, Gross D. Knowledge and attitudes on electroconvulsive therapy in Germany: A web based survey. Psychiatry Res. 2018 Apr;262:407-412. doi: 10.1016/j.psychres.2017.09.015. Epub 2017 Sep 11.
PubMed 28923432Wilkinson D, Daoud J. The stigma and the enigma of ECT. Int J Geriatr Psychiatry. 1998 Dec;13(12):833-5. doi: 10.1002/(sici)1099-1166(1998120)13:123.0.co;2-r. No abstract available.
PubMed 9884906Dwork AJ, Arango V, Underwood M, Ilievski B, Rosoklija G, Sackeim HA, Lisanby SH. Absence of histological lesions in primate models of ECT and magnetic seizure therapy. Am J Psychiatry. 2004 Mar;161(3):576-8. doi: 10.1176/appi.ajp.161.3.576.
PubMed 14992989Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 2010 Sep 15;68(6):568-77. doi: 10.1016/j.biopsych.2010.06.009. Epub 2010 Jul 31.
PubMed 20673880Payne NA, Prudic J. Electroconvulsive therapy: Part I. A perspective on the evolution and current practice of ECT. J Psychiatr Pract. 2009 Sep;15(5):346-68. doi: 10.1097/01.pra.0000361277.65468.ef.
PubMed 19820553Prudic J, Peyser S, Sackeim HA. Subjective memory complaints: a review of patient self-assessment of memory after electroconvulsive therapy. J ECT. 2000 Jun;16(2):121-32. doi: 10.1097/00124509-200006000-00004.
PubMed 10868322
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of the Cognitive Effects of Electroconvulsive Therapy Via Machine Learning and Neuroimaging
- ClinicalTrials.gov ID
- NCT03490149
- Acronym / sponsor ID
- CoEffECT / CoEffECT - Study
- Conditions
- ECT, Depression, Cognitive Impairment, Memory Impairment
- Keywords
- ECT, Electroconvulsive Therapy, Depression, Memory, Memory Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Apr 2018 (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 study aims to use machine learning to predict the occurrence of episodic and autobiographical memory deficits as well as treatment response following a course of electroconvulsive therapy. Additionally, the neurophysiological correlates of the cognitive effects after a course of ECT will be investigated.
Therefore, structural, resting-state and diffusion tensor images will be collected within one week before the first and after the last ECT treatment from severely depressed patients. Standard measures of cognitive function and specifically episodic as well as autobiographical memory will also be collected longitudinally and used for prediction. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression, 60 medication-only controls and 60 healthy controls.
Detailed description
Due to the immense disease burden of major depression and unsatisfactory response to standard pharmacological and psychological treatments, the need for treatment alternatives is evident. Electroconvulsive therapy (ECT) remains to be the most efficacious treatment known for treatment-resistant depression. However, although many studies show response rates above 70%, ECT can be considered vastly underused. Reasons contributing to this phenomenon may include stigma, regulatory restrictions, limited medical training, safety and side-effect concerns, or reluctance among professionals to recommend ECT. Most of these reasons have already been refuted or put into perspective by psychological and neuroscientific studies (e.g. ECT causes brain lesions) and most cognitive deficits related to the ECT course seem to fade after several weeks of discontinuation.
Still, in terms of the tolerability, memory disturbances remain the most problematic effect of ECT. Besides subjective reports from patients after a course of ECT, experimental studies have also found evidence of episodic and autobiographical memory impiarment attributable to ECT. The origins of these effects are still largely unknown and remain a goal for further research.
It has now been shown that structural T1 weighted MR-images can be used to predict the response to a course of ECT via machine learning. Therefore, this study aims to use machine learning to predict the occurrence of episodic and specifically autobiographical memory deficits arising within a course of electroconvulsive therapy based on MR-images collected within one week before the first ECT treatment from severely depressed patients. Additionally, the neurophysiological correlates of the cognitive effects modulated by a course of ECT will be investigated longitudinally through the use of structural, resting-state and diffusion tensor images. The study consists of 60 ECT receiving inpatients suffering from major unipolar or bipolar depression.
If successful, this line of research should lead to a better tolerability of ECT by aiding in the complex decision making process involved in prescribing ECT as well as the parameter setting within a treatment course (e.g. uni- vs. bilateral).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECT | – | Device: Electroconvulsive Therapy |
| Medication - Treatment as usual | – | Drug: Medication - Treatment as usual |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Inpatients at the psychiatric hospital of the University Hospital Bonn. The patients diagnosis of major depressive disorder will be verified via the structured clinical interview for DSM-5. ECT protocol in line with international standards administered by a staff psychiatrist. Additionally, a medication-only and a healthy control sample are included in the study.
Key inclusion criteria (7 listed)
- The duration of the current depressive episode is at least four weeks
- The duration of the current depressive episode is less than five years
- Inpatients of the psychiatric clinic of the University Hospital Bonn and eligible for ECT because of major depressive disorder or major depressive episode in bipolar disorder (according to DSM-5 criteria)
- Score on HDRS 28 ≥ 20
- Ability to understand the purpose of and procedures required for the study and willingness to consent to participation
Key exclusion criteria (11 listed)
- No lifetime occurence of a personality disorder
- Current (or within the last year) posttraumatic stress disorder
- Schizophrenia or any other psychotic disorder except for psychotic depression
- Severe somatic or neurological condition (e.g. stroke)
- Head trauma resulting in unconsciousness for more than 5 minutes
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 |
|---|---|---|
| Electroconvulsive TherapySeries of electroconvulsive therapy for major depressive disorder | Device | ECT |
| Medication - Treatment as usualMedication only sample - Treatment as usual | Drug | Medication - Treatment as usual |
Primary outcome
Change in auditory verbal learning performance
Time frame: Within one week before first and one week after last ECT
Auditory Verbal Learning Test (AVLT)
Change in autobiographical memory performance
Time frame: Within one week before first and one week after last ECT
Autobiographical Memory Interview (AMI-SF)
Change in subjective memory impairment
Time frame: Within one week before first and one week after last ECT
Qualitative Interview
Occurence of retrograde amnesia
Time frame: Within the first week after last ECT
2 secondary outcomes
Change in depression severity as measured by the Hamilton Depression Rating Scale (HDRS 28).
Time frame: One week before first and one week after last ECT
Change in depression severity as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: One week before first and one week after last ECT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 23993280Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
- Background: PubMed 20370962Sinyor M, Schaffer A, Levitt A. The sequenced treatment alternatives to relieve depression (STAR*D) trial: a review. Can J Psychiatry. 2010 Mar;55(3):126-35. doi: 10.1177/070674371005500303.
- Background: PubMed 12642045UK ECT Review Group. Efficacy and safety of electroconvulsive therapy in depressive disorders: a systematic review and meta-analysis. Lancet. 2003 Mar 8;361(9360):799-808. doi: 10.1016/S0140-6736(03)12705-5.
- Background: PubMed 26528644Haq AU, Sitzmann AF, Goldman ML, Maixner DF, Mickey BJ. Response of depression to electroconvulsive therapy: a meta-analysis of clinical predictors. J Clin Psychiatry. 2015 Oct;76(10):1374-84. doi: 10.4088/JCP.14r09528.
- Background: PubMed 28658461Sackeim HA. Modern Electroconvulsive Therapy: Vastly Improved yet Greatly Underused. JAMA Psychiatry. 2017 Aug 1;74(8):779-780. doi: 10.1001/jamapsychiatry.2017.1670. No abstract available.
- Background: PubMed 28658489Slade EP, Jahn DR, Regenold WT, Case BG. Association of Electroconvulsive Therapy With Psychiatric Readmissions in US Hospitals. JAMA Psychiatry. 2017 Aug 1;74(8):798-804. doi: 10.1001/jamapsychiatry.2017.1378.
- Background: PubMed 27798050Aoki Y, Yamaguchi S, Ando S, Sasaki N, Bernick PJ, Akiyama T. The experience of electroconvulsive therapy and its impact on associated stigma: A meta-analysis. Int J Soc Psychiatry. 2016 Dec;62(8):708-718. doi: 10.1177/0020764016675379. Epub 2016 Oct 26.
- Background: PubMed 9871847Bailine S. Reimbursement and documentation issues in an ambulatory ECT program. J ECT. 1998 Dec;14(4):255-8.
- Background: PubMed 23059049Case BG, Bertollo DN, Laska EM, Price LH, Siegel CE, Olfson M, Marcus SC. Declining use of electroconvulsive therapy in United States general hospitals. Biol Psychiatry. 2013 Jan 15;73(2):119-26. doi: 10.1016/j.biopsych.2012.09.005. Epub 2012 Oct 8.
- Background: PubMed 28923432Wilhelmy S, Rolfes V, Grozinger M, Chikere Y, Schottle S, Gross D. Knowledge and attitudes on electroconvulsive therapy in Germany: A web based survey. Psychiatry Res. 2018 Apr;262:407-412. doi: 10.1016/j.psychres.2017.09.015. Epub 2017 Sep 11.
- Background: PubMed 9884906Wilkinson D, Daoud J. The stigma and the enigma of ECT. Int J Geriatr Psychiatry. 1998 Dec;13(12):833-5. doi: 10.1002/(sici)1099-1166(1998120)13:123.0.co;2-r. No abstract available.
- Background: PubMed 14992989Dwork AJ, Arango V, Underwood M, Ilievski B, Rosoklija G, Sackeim HA, Lisanby SH. Absence of histological lesions in primate models of ECT and magnetic seizure therapy. Am J Psychiatry. 2004 Mar;161(3):576-8. doi: 10.1176/appi.ajp.161.3.576.
- 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.
Rene Hurlemann, Prof. study director
University Hospital, Bonn
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 ECT and Depression, run by University Hospital, Bonn at 1 site in Germany.
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 7 inclusion and 11 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 May 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 Germany. 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 Maximilian Kiebs, M.Sc. (0049228287 ext. 19710, m.kiebs@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in auditory verbal learning performance (time frame: Within one week before first and one week after last ECT). The study lists 4 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 NCT03490149, which also lists 19 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 25 May 2022.