Old AgeNCT04783103
Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
A study testing a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil in people with Old Age and Depressive Disorder, Treatment-Resistant, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
To evaluate safety and efficacy of an accelerated deep brain Transcranial Magnetic stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) protocol in an elderly depressed patient population Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Old Age, Depressive Disorder, Treatment-Resistant
- What is being tested?
- a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2021to Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- • In- and outpatients (age 65 year or older).
- Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for unipolar depression according 17-item Hamilton depression rating scale (HDRS-17) score of 17 or more.
- Failed to respond to at least one adequate course with an antidepressant medication trial, including the current one.
- Intention to continue the current (>6 weeks) antidepressant treatment at a stable dose dur-ing the stimulation.
- Benzodiazepines are permitted up to a maximum dose of 40 mg diazepam or equivalent. If the dosage has been recently changed, it should be stable for at least 2 weeks.
- Able to read, understand and sign the Informed Consent Form.
Who cannot join
- • Psychosis (except depression with psychotic features).
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, substance abuse, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) with the exception of dental fillings. The presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with the following neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with (study related) MRI.
- Patients with cognitive disturbances or dementia (Mini Mental State) < 24.
- Suicide attempt within 6 months before the start of the study or present high risk of suicide per the investigator's clinical judgment and indicative response* on the Columbia-Suicide Severity Rating Scale (C-SSRS) and 21-items Beck Scale for Suicide Ideation (BSI). *'yes' on Item 5 (active suicidal ideation with specific plan and intent).
- Any change in the habitual psychopharmacological agents will be considered as dropout.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Dieter Zeeuws, MD, +324777722, dieter.zeeuws@uzbrussel.be
Chris Baeken, MD PhD, 324776425, Chris.baeken@uzbrussel.be
About this study
Official title: Neuromodulation in the Elderly Depressed: a Brain Im-aging Pilot Study
To evaluate safety and efficacy of an accelerated deep brain Transcranial Magnetic stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) protocol in an elderly depressed patient population
Read the detailed description
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS) and transcutaneous direct current stimulation (tDCS) may offer a solution. Given our recent positive results with accelerated rTMS in the elderly depressed, we want to continue to develop non-invasive treatment stimulations. The FDA approved deep brain TMS (dTMS) technique may be a promising option, targeting the brain underneath the neocortex with potentially better response and remission rates. Therefore, in a sham-controlled randomized controled trial, we will treat 44 geriatric depressed patients with accelerated dTMS (5 sessions/day over 4 days only), and evaluate clinical efficacy and safety. One week after the last adTMS or sham treatment, all patients will have access to active treatment in a 3 week open label transcutaneous direct current stimulation (tDCS) with a home-use device. In this manner we can examine clinnical effect of tDCS in the adTMS-sham group as well as the possible maintenance effect of tDCS in the adTMS active treatment group. Because new introduced neuromodulation paradigms should be rigorously neurobiologically examined before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of these applications in order to optimize response prediction and treatment. Gut microbes can influence human metabolism, nutrition, physiology and immune status. The "microbiota-gut-brain axis" entails a continues exchange of information between the gut and central nervous system. Several clinical and preclinical studies have emphasized the bidirectional role of microbiome disruption in depression and depression-like behavior. In the current project, we also will examine the effects of neurostimulation treatments on the gut microbiome.
- Conditions
- Old Age, Depressive Disorder, Treatment-Resistant
- Being tested
- a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coilDevice
Also called Sooma tDCS (open label)
3 weeks home use
| Study group | Role | What they receive |
|---|---|---|
| Active adTMS | Active comparator | Subjects in the treatment arm receive 20 sessions of real adTMS . The sessions will be spread over the four succeeding days (5 sessions daily on Tuesday, Wednesday, Thursday and Friday). Receives: Device: a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil |
| Sham adTMS | Sham comparator | Subject in the control/Placebo/Sham arm receive 20 sessions of sham adTMS. The sessions will be spread over the four succeeding days (5 sessions daily on Tuesday, Wednesday, Thursday and Friday). Receives: Device: a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical effect of adTMS (Changes in depression severity clinician-rated and self-report)
To investigate the effect of adTMS delivered by a H1 coil to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD.-measured by change in the 17 item Hamilton Depression rating Scale score. For a total score between 0 and 48, the higher the total score the more severe the depression. Response is reduction from baseline of ≥ 50% in the total score and remission is a total HAMD-17 score ≤ 7.
- measured by change in the Beck-Inventory of Depression-II score. For a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission and BDI-II score decrease of 50% from baseline is the criterion for treatment response.
- measured by change in the Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score.
Measured: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
Secondary outcomes (12)
Clinical effect of tDCS 17 item Hamilton Depression rating Scale score
To investigate the effect of tdCS delivered by a Sooma tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD.-measured by change in the 17 item Hamilton Depression rating Scale score. For a total score between 0 and 48, the higher the total score the more severe the depression. Response is reduction from baseline of ≥ 50% in the total score and remission is a total HAMD-17 score ≤ 7.
Measured: Day 15 (+/-3d) Day 36 (+/-3d)
Clinical effect of tDCS Beck-Inventory of Depression-II score
To investigate the effect of tdCS delivered by a Sooma tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD.-measured by change in the Beck-Inventory of Depression-II score. For a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission and BDI-II score decrease of 50% from baseline is the criterion for treatment response.
Measured: Day 15 (+/-3d) Day 36 (+/-3d)
Clinical effect of tDCS Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score
To investigate the effect of tdCS delivered by a Sooma tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD.-measured by change in the Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score. Score of ≤6 is the criterion for remission and decrease of 50% from baseline is the criterion for treatment response.
Measured: Day 15 (+/-3d) Day 36 (+/-3d)
maintenance effect of tDCS 17 item Hamilton Depression rating Scale score
To investigate the maintenance effect of tdCS delivered by a Sooma tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD who responded to active adTMS measured by reduction from baseline of ≥ 50% in the total score in the 17 item Hamilton Depression rating Scale score. Maintenance effect occurs if the responders scores at day 15 remain or are lower on day 36.
Measured: Day 15 (+/-3d) Day 36 (+/-3d)
maintenance effect of tDCS Beck-Inventory of Depression-II score
To investigate the maintenance effect of tdCS delivered by a Sooma tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD who responded to active adTMS measured by reduction from baseline of ≥ 50% in the total score in the BDI-II score decrease of 50% from baseline in the Beck-Inventory of Depression-II score. Maintenance effect occurs if the responders scores at day 15 remain or are lower on day 36.
Measured: Day 15 (+/-3d) Day 36 (+/-3d)
functional magnetic resonance imaging changes pre/post treatment in gender task as an incidental measure of emotional processing and probe of limbic function, and it's predictive value for response
To investigate if the fMRI gender task provides an incidental measure of emotional processing and could be a better probe of limbic function, and it's predictive value for response to adTMS and/or tDCS.To look for change post-pre intervention in the fMRI gender task response.
Measured: Day 1 (+/-3d), Day 8 (+/-3d)
effect on cognition MMSE
To investigate the effect of adTMS and tDCS on cognition as measured by increase in Mini Mental State examination scores.Scores range from 0 to 30, a score increase indicates improvement.
Measured: screening, Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
Incidence of Treatment-Emergent Adverse Events assessed with the Adverse Events questionnaire
To investigate the safety profile of adTMS and tDCS for elderly with MDD
Measured: Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on suicide risk as measured by change in C-SSRS
To investigate the effect of adTMS and tDCS on suicide risk of elderly patients with MDD.
Measured: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on suicide risk as measured by change in BSI
To investigate the effect of adTMS and tDCS on suicide risk of elderly patients with MDD.
Measured: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on the gut microbiome
To investigate the effect of neurostimulation on the gut microbiome in elderly with MDD.
Measured: Day 1 (+/-3d), Day 8 (+/-3d) Day 36 (+/-3d)
possible neuroimaging biological markers for response
To investigate possible neurobiological markers for response to adTMS and/or tDCS by neuro imaging changes after adTMS and/or tDCS compared to baseline. Pre/Post changes in resting state fMRI en ASL (bloodflow) images.
Measured: Day 1 (+/-3d), Day 8 (+/-3d) Day 36 (+/-3d)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start7 May 2021
- Primary completionFeb 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Old AgeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- In a sham-controlled randomized controlled trial, we will treat 44 geriatric depressed patients with accelerated dTMS (adTMS) (5 sessions/day over 4 days) and evaluate clinical efficacy and safety. One week after the last adTMS or sham treatment, all patients will have access to active treatment in a 3 week open label transcutaneous direct current stimulation (tDCS) with a home-use device. In this manner we can examine clinical effect of tDCS in the adTMS-sham group as well as the possible maintenance effect of tDCS in the adTMS active treatment group. Because newly introduced neuromodulation paradigms should go through profound neurobiological testing before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of these applications in order to optimize response prediction and treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dieter Zeeuws, Universitair Ziekenhuis Brussel
- Investigators
- Dieter Zeeuws, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783103
- Sponsor's protocol ID
- 2020/324
- Status last verified
- Nov 2022
- First submitted
- 15 Feb 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be disclosed after publication
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation in the Elderly Depressed: a Brain Im-aging Pilot Study
- ClinicalTrials.gov ID
- NCT04783103
- Acronym / sponsor ID
- 2020/324
- Conditions
- Old Age, Depressive Disorder, Treatment-Resistant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Mar 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.
To evaluate safety and efficacy of an accelerated deep brain Transcranial Magnetic stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) protocol in an elderly depressed patient population
Detailed description
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS) and transcutaneous direct current stimulation (tDCS) may offer a solution. Given our recent positive results with accelerated rTMS in the elderly depressed, we want to continue to develop non-invasive treatment stimulations. The FDA approved deep brain TMS (dTMS) technique may be a promising option, targeting the brain underneath the neocortex with potentially better response and remission rates. Therefore, in a sham-controlled randomized controled trial, we will treat 44 geriatric depressed patients with accelerated dTMS (5 sessions/day over 4 days only), and evaluate clinical efficacy and safety. One week after the last adTMS or sham treatment, all patients will have access to active treatment in a 3 week open label transcutaneous direct current stimulation (tDCS) with a home-use device. In this manner we can examine clinnical effect of tDCS in the adTMS-sham group as well as the possible maintenance effect of tDCS in the adTMS active treatment group. Because new introduced neuromodulation paradigms should be rigorously neurobiologically examined before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of these applications in order to optimize response prediction and treatment. Gut microbes can influence human metabolism, nutrition, physiology and immune status. The "microbiota-gut-brain axis" entails a continues exchange of information between the gut and central nervous system. Several clinical and preclinical studies have emphasized the bidirectional role of microbiome disruption in depression and depression-like behavior. In the current project, we also will examine the effects of neurostimulation treatments on the gut microbiome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- In a sham-controlled randomized controlled trial, we will treat 44 geriatric depressed patients with accelerated dTMS (adTMS) (5 sessions/day over 4 days) and evaluate clinical efficacy and safety. One week after the last adTMS or sham treatment, all patients will have access to active treatment in a 3 week open label transcutaneous direct current stimulation (tDCS) with a home-use device. In this manner we can examine clinical effect of tDCS in the adTMS-sham group as well as the possible maintenance effect of tDCS in the adTMS active treatment group. Because newly introduced neuromodulation paradigms should go through profound neurobiological testing before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of these applications in order to optimize response prediction and treatment
| Arm | Type | Receives |
|---|---|---|
| Active adTMS | Active comparator | Device: a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coilSubjects in the treatment arm receive 20 sessions of real adTMS . The sessions will be spread over the four succeeding days (5 sessions daily on Tuesday, Wednesday, Thursday and Friday). |
| Sham adTMS | Sham comparator | Device: a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coilSubject in the control/Placebo/Sham arm receive 20 sessions of sham adTMS. The sessions will be spread over the four succeeding days (5 sessions daily on Tuesday, Wednesday, Thursday and Friday). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- • In- and outpatients (age 65 year or older).
Key exclusion criteria (5 listed)
- • Psychosis (except depression with psychotic features).
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 |
|---|---|---|
| a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coilAlso: Sooma tDCS (open label)3 weeks home use | Device | Active adTMS, Sham adTMS |
Primary outcome
Clinical effect of adTMS (Changes in depression severity clinician-rated and self-report)
Time frame: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
To investigate the effect of adTMS delivered by a H1 coil to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD.-measured by change in the 17 item Hamilton Depression rating Scale score. For a total score between 0 and 48, the higher the total score the more severe the depression. Response is reduction from baseline of ≥ 50% in the total score and remission is a total HAMD-17 score ≤ 7. * measured by change in the Beck-Inventory of Depression-II score. For a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission and BDI-II score decrease of 50% from baseline is the criterion for treatment response. * measured by change in the Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score.
12 secondary outcomes
Clinical effect of tDCS 17 item Hamilton Depression rating Scale score
Time frame: Day 15 (+/-3d) Day 36 (+/-3d)
Clinical effect of tDCS Beck-Inventory of Depression-II score
Time frame: Day 15 (+/-3d) Day 36 (+/-3d)
Clinical effect of tDCS Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score
Time frame: Day 15 (+/-3d) Day 36 (+/-3d)
maintenance effect of tDCS 17 item Hamilton Depression rating Scale score
Time frame: Day 15 (+/-3d) Day 36 (+/-3d)
maintenance effect of tDCS Beck-Inventory of Depression-II score
Time frame: Day 15 (+/-3d) Day 36 (+/-3d)
functional magnetic resonance imaging changes pre/post treatment in gender task as an incidental measure of emotional processing and probe of limbic function, and it's predictive value for response
Time frame: Day 1 (+/-3d), Day 8 (+/-3d)
effect on cognition MMSE
Time frame: screening, Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
Incidence of Treatment-Emergent Adverse Events assessed with the Adverse Events questionnaire
Time frame: Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on suicide risk as measured by change in C-SSRS
Time frame: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on suicide risk as measured by change in BSI
Time frame: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on the gut microbiome
Time frame: Day 1 (+/-3d), Day 8 (+/-3d) Day 36 (+/-3d)
possible neuroimaging biological markers for response
Time frame: Day 1 (+/-3d), Day 8 (+/-3d) Day 36 (+/-3d)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: Yes. All data will be disclosed after publication
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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.
Dieter Zeeuws, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil in people with Old Age and Depressive Disorder, Treatment-Resistant, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 5 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 3 Nov 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 Belgium. 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. Some participants in this study may receive a placebo. 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 Dieter Zeeuws, MD (+324763459, dieter.zeeuws@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical effect of adTMS (Changes in depression severity clinician-rated and self-report) (time frame: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)). 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 3 Nov 2022.