Anxiety DisordersNCT03680664
Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS)
A study testing Active tDCS and MBSR in people with Anxiety Disorders and Mood Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
Ideal interventions for the older aged population would be those that are easily accessible and associated with minimal burden on family members, the healthcare system and the individuals themselves. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Anxiety Disorders, Mood Disorders, Transcranial Direct Current Stimulation
- What is being tested?
- Active tDCS and MBSR
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 8 Nov 2018to 4 Jul 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling men and women aged 60 or above.
- Current cognitive complaints per participant self-report, but with intact cognitive function as defined by a score of 0-9 on the Short Blessed Test (SBT) and a Montreal Cognitive Assessment (MoCA) score ≥25 per PI discretion.
- PROMIS depression scale score of greater or equal to 16 and/or PROMIS anxiety score greater or equal to 14.
- Ability to read and speak English fluently enough to complete all research assessments.
- Corrected visual ability to read newspaper headlines.
- Hearing capacity to respond to a raised conversational voice.
- Willingness and ability to provide informed consent.
Who cannot join
- Diagnostic and Statistical Manual IV (DSM-IV) criteria for current or life-time bipolar disorder, schizophrenia, schizoaffective disorder or any other psychotic disorders.
- Untreated post-traumatic stress disorder.
- A MoCA score <25 or a score greater than 9 on the SBT, per PI discretion
- Use of cognitive enhancers such as anticholinergic medications within the past 6weeks.
- DSM-IV criteria for any substance dependence within the past 6 months that would affect their participation, per PI discretion.
- Unstable medical illness (e.g. uncontrolled diabetes mellitus or hypertension).
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- Concurrent cognitive training, such as brain-training software, participation in psychotherapy or regular engagement in mindfulness practice and/or yoga.
- Taking anticonvulsant or antipsychotics that cannot be safely tapered and discontinued.
- Significant neurological condition (e.g. stroke, seizure disorder, multiple sclerosis).
- A pace-maker or other metal implants that would preclude safe use of tDCS.
- Intelligence Quotient (IQ) < 70 as estimated by the Wechsler Test of Adult Reading.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Cognition in Older Persons: A Randomized Controlled Trial of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS)
Ideal interventions for the older aged population would be those that are easily accessible and associated with minimal burden on family members, the healthcare system and the individuals themselves. Mindfulness-Based Stress Reduction (MBSR) therapy and Transcranial Direct Current Stimulation (tDCS) are two interventions that may be effective in targeting cognitive deficits in individuals with anxiety, depression, and/or cognitive complaints. MBSR has been shown to decrease symptoms of depression and improve cognition and tDCS has been shown to improve cognition in the older aged population. The effectiveness of these two interventions combined to elicit changes in cognition has yet to be demonstrated. Therefore, the overall aim of the current research is to evaluate the efficacy of a combination of MBSR and tDCS to improve cognitive function in individuals with cognitive complaints and symptoms of anxiety and/or depression.
This will be a randomized pilot study. Sixteen individuals (separated into 2 groups of 8) will be randomized to receive a combination MBSR + active tDCS or MBSR + sham tDCS over 8 weeks. Participants will visit the Centre for Addiction and Mental Health (CAMH) once per week for in-class group sessions and will complete the intervention daily at home for the duration of the study. Participants will be aged 60 and older with cognitive complaints, with symptoms of anxiety and/or depression. Participants will be trained to self-administer tDCS and given guidelines for the completion of daily MBSR activities at home. It is hypothesized that the combination of active tDCS + MBSR will enhance cognition compared to the combination of sham tDCS + MBSR.
Read the detailed description
Neurocognitive difficulties are a common problem in the older adult population. Previous research has shown memory complaints are higher in older adults with depression or anxiety versus those without these diagnoses. This suggests that mood symptoms, or a diagnosis of a mood disorder, may represent significant predictors of cognitive impairment. If left untreated, symptoms of depression and memory complaints may lead to greater cognitive impairment i.e. Mild Cognitive Impairment (MCI) and diagnosis of dementia . Therefore, early interventions are urgently needed to prevent decline in memory and cognitive function in individuals with MCI, depression, and/or anxiety.
This will be a randomized study design. Uo to 24 individuals (n=8 per group) will be randomized to receive a combination of 8-weeks of in-class group MBSR + active or sham tDCS and daily at-home MBSR + tDCS (active or sham). Each individual must be: (1) 60 or above; (2) present with cognitive complaints but not frank cognitive impairment (at a level of mild dementia or greater); and (3) present with a diagnosis or symptoms of depressed mood and/or anxiety.
Symptoms related to cognition, memory, and mood symptoms will be assessed at baseline (T0), throughout the study, as described in the MBSR protocol, and upon completion of the 8-week treatment course (Tx). Each study participant will have a clinical assessment at both T0 and Tx. Clinicians, participants and assessors will be blinded to the tDCS condition. These assessments will confirm any diagnoses and monitor clinical stability, including possible progression of participants to a diagnosis of a mood and/or anxiety disorder(s) or dementia. Any participant that progresses into a clinical diagnosis of dementia will be excluded from the study and referred to an appropriate level of care based on the severity of their symptoms.
To train participants on the tDCS intervention, each individual will attend one-week of in-class training sessions prior to initiating the 8-week study. Participants will come to the Centre for Addiction and Mental Health (CAMH) for 5 days leading up to the initiation of the MBSR treatment for tDCS self-administration training. On the final day of tDCS training, participants will attend a 2.5 hour in-class MBSR orientation session. Following this, the 8-week course of daily MBSR + tDCS will begin with an initial orientation session. The remaining 8 weeks of the at-home MBSR + tDCS intervention will be self-conducted at each participant's place of residence, with the exception of the weekly MBSR class each participant will be required to attend at CAMH. The study coordinator will be available by phone to the participants throughout the study.
- Conditions
- Anxiety Disorders, Mood Disorders, Transcranial Direct Current Stimulation, tDCS, Stress Reduction
- Being tested
- Active tDCS, sham tDCS, MBSR
- Keywords
- Mild Cognitive Impairment, Dementia, Mindfulness
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
Also called Transcranial Direct Current Stimulation
Excitatory bilateral stimulation to the frontal lobes, in particular the left and right DLPFC, will be applied. The anode will be placed at Fz and the cathode at Iz to achieve this bilateral frontal excitatory stimulation. Rubber electrodes will be inserted in 35-cm2 saline-soaked sponges and fixed with a headband. The direct current will be of 2 mA (current density = 0.57 A/m2) for 30 min per day.
sham tDCSOther
The same tDCS parameters as as the active condition will be used; however, the device will be turned off after 1 minute of active stimulation.
MBSRBehavioural
Also called Mindfulness-Based Stress Reduction
After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with CDs of meditative practice.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS + MBSR | Experimental | Excitatory bilateral stimulation to the frontal lobes, in particular the left and right DLPFC, will be applied. The anode will be placed at Fz and the cathode at Iz to achieve this bilateral frontal excitatory stimulation. Rubber electrodes will be inserted in 35-cm2 saline-soaked sponges and fixed with a headband. The direct current will be of 2 milliamps (mA) (current density = 0.57 A/m2) for 30 min per day.
After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with Compact Discs-Read Only Memory (CD-ROMs) of meditative practice. Receives: Device: Active tDCS; Behavioral: MBSR |
| sham tDCS + MBSR | Sham comparator | The same tDCS parameters as as the active condition will be used; however, the device will be turned off after 1 minute of active stimulation.
After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with CDs of meditative practice. Receives: Other: sham tDCS; Behavioral: MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive and memory function
Cognitive and memory function measured by a neuropsychological battery examining memory, executive functioning and attention
Measured: Baseline, Approximately 10-14 weeks after baseline
Secondary outcomes (4)
Change in depressive symptoms
Depressive symptoms as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) depressive symptoms
Measured: Baseline, Approximately 10-14 weeks after baseline
Change in anxiety symptoms
Anxiety symptoms as as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety symptoms
Measured: Baseline, Approximately 10-14 weeks after baseline
Change in quality of life
Quality of Life as assessed by PROMIS Scale for Ability to Participate in Social Roles and Activities, the PROMIS Scale for Satisfaction with Social Roles and Activities and the
Measured: Baseline, Approximately 10-14 weeks after baseline
Change in mindfulness
Mindfulness as assessed by Cognitive Affective Mindfulness Scale - Revised (CAMS-R)
Measured: Baseline, Approximately 10-14 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start8 Nov 2018
- Primary completion4 Jul 2019
- Study completion4 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Tarek Rajji, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680664
- Sponsor's protocol ID
- 065/2017
- Status last verified
- Jan 2020
- First submitted
- 18 Sep 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Brooks H, Oughli HA, Kamel L, Subramanian S, Morgan G, Blumberger DM, Kloeckner J, Kumar S, Mulsant BH, Lenze EJ, Rajji TK. Enhancing Cognition in Older Persons with Depression or Anxiety with a Combination of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS): Results of a Pilot Randomized Clinical Trial. Mindfulness (N Y). 2021;12(12):3047-3059. doi: 10.1007/s12671-021-01764-9. Epub 2021 Oct 5.
PubMed 34630733
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cognition in Older Persons: A Randomized Controlled Trial of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS)
- ClinicalTrials.gov ID
- NCT03680664
- Acronym / sponsor ID
- 065/2017
- Conditions
- Anxiety Disorders, Mood Disorders, Transcranial Direct Current Stimulation, tDCS, Stress Reduction
- Keywords
- Mild Cognitive Impairment, Dementia, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 4 Jul 2019 (actual)
- Study completion
- 4 Jul 2019 (actual)
- First posted
- 21 Sep 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.
Ideal interventions for the older aged population would be those that are easily accessible and associated with minimal burden on family members, the healthcare system and the individuals themselves. Mindfulness-Based Stress Reduction (MBSR) therapy and Transcranial Direct Current Stimulation (tDCS) are two interventions that may be effective in targeting cognitive deficits in individuals with anxiety, depression, and/or cognitive complaints. MBSR has been shown to decrease symptoms of depression and improve cognition and tDCS has been shown to improve cognition in the older aged population. The effectiveness of these two interventions combined to elicit changes in cognition has yet to be demonstrated. Therefore, the overall aim of the current research is to evaluate the efficacy of a combination of MBSR and tDCS to improve cognitive function in individuals with cognitive complaints and symptoms of anxiety and/or depression.
This will be a randomized pilot study. Sixteen individuals (separated into 2 groups of 8) will be randomized to receive a combination MBSR + active tDCS or MBSR + sham tDCS over 8 weeks. Participants will visit the Centre for Addiction and Mental Health (CAMH) once per week for in-class group sessions and will complete the intervention daily at home for the duration of the study. Participants will be aged 60 and older with cognitive complaints, with symptoms of anxiety and/or depression. Participants will be trained to self-administer tDCS and given guidelines for the completion of daily MBSR activities at home. It is hypothesized that the combination of active tDCS + MBSR will enhance cognition compared to the combination of sham tDCS + MBSR.
Detailed description
Neurocognitive difficulties are a common problem in the older adult population. Previous research has shown memory complaints are higher in older adults with depression or anxiety versus those without these diagnoses. This suggests that mood symptoms, or a diagnosis of a mood disorder, may represent significant predictors of cognitive impairment. If left untreated, symptoms of depression and memory complaints may lead to greater cognitive impairment i.e. Mild Cognitive Impairment (MCI) and diagnosis of dementia . Therefore, early interventions are urgently needed to prevent decline in memory and cognitive function in individuals with MCI, depression, and/or anxiety.
This will be a randomized study design. Uo to 24 individuals (n=8 per group) will be randomized to receive a combination of 8-weeks of in-class group MBSR + active or sham tDCS and daily at-home MBSR + tDCS (active or sham). Each individual must be: (1) 60 or above; (2) present with cognitive complaints but not frank cognitive impairment (at a level of mild dementia or greater); and (3) present with a diagnosis or symptoms of depressed mood and/or anxiety.
Symptoms related to cognition, memory, and mood symptoms will be assessed at baseline (T0), throughout the study, as described in the MBSR protocol, and upon completion of the 8-week treatment course (Tx). Each study participant will have a clinical assessment at both T0 and Tx. Clinicians, participants and assessors will be blinded to the tDCS condition. These assessments will confirm any diagnoses and monitor clinical stability, including possible progression of participants to a diagnosis of a mood and/or anxiety disorder(s) or dementia. Any participant that progresses into a clinical diagnosis of dementia will be excluded from the study and referred to an appropriate level of care based on the severity of their symptoms.
To train participants on the tDCS intervention, each individual will attend one-week of in-class training sessions prior to initiating the 8-week study. Participants will come to the Centre for Addiction and Mental Health (CAMH) for 5 days leading up to the initiation of the MBSR treatment for tDCS self-administration training. On the final day of tDCS training, participants will attend a 2.5 hour in-class MBSR orientation session. Following this, the 8-week course of daily MBSR + tDCS will begin with an initial orientation session. The remaining 8 weeks of the at-home MBSR + tDCS intervention will be self-conducted at each participant's place of residence, with the exception of the weekly MBSR class each participant will be required to attend at CAMH. The study coordinator will be available by phone to the participants throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS + MBSR | Experimental | Device: Active tDCS, Behavioral: MBSRExcitatory bilateral stimulation to the frontal lobes, in particular the left and right DLPFC, will be applied. The anode will be placed at Fz and the cathode at Iz to achieve this bilateral frontal excitatory stimulation. Rubber electrodes will be inserted in 35-cm2 saline-soaked sponges and fixed with a headband. The direct current will be of 2 milliamps (mA) (current density = 0.57 A/m2) for 30 min per day. After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with Compact Discs-Read Only Memory (CD-ROMs) of meditative practice. |
| sham tDCS + MBSR | Sham comparator | Other: sham tDCS, Behavioral: MBSRThe same tDCS parameters as as the active condition will be used; however, the device will be turned off after 1 minute of active stimulation. After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with CDs of meditative practice. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Community-dwelling men and women aged 60 or above.
- Current cognitive complaints per participant self-report, but with intact cognitive function as defined by a score of 0-9 on the Short Blessed Test (SBT) and a Montreal Cognitive Assessment (MoCA) score ≥25 per PI discretion.
- PROMIS depression scale score of greater or equal to 16 and/or PROMIS anxiety score greater or equal to 14.
- Ability to read and speak English fluently enough to complete all research assessments.
- Corrected visual ability to read newspaper headlines.
Key exclusion criteria (11 listed)
- Diagnostic and Statistical Manual IV (DSM-IV) criteria for current or life-time bipolar disorder, schizophrenia, schizoaffective disorder or any other psychotic disorders.
- Untreated post-traumatic stress disorder.
- A MoCA score <25 or a score greater than 9 on the SBT, per PI discretion
- Use of cognitive enhancers such as anticholinergic medications within the past 6weeks.
- DSM-IV criteria for any substance dependence within the past 6 months that would affect their participation, per PI discretion.
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 |
|---|---|---|
| Active tDCSAlso: Transcranial Direct Current StimulationExcitatory bilateral stimulation to the frontal lobes, in particular the left and right DLPFC, will be applied. The anode will be placed at Fz and the cathode at Iz to achieve this bilateral frontal excitatory stimulation. Rubber electrodes will be inserted in 35-cm2 saline-soaked sponges and fixed with a headband. The direct current will be of 2 mA (current density = 0.57 A/m2) for 30 min per day. | Device | Active tDCS + MBSR |
| sham tDCSThe same tDCS parameters as as the active condition will be used; however, the device will be turned off after 1 minute of active stimulation. | Other | sham tDCS + MBSR |
| MBSRAlso: Mindfulness-Based Stress ReductionAfter a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with CDs of meditative practice. | Behavioural | Active tDCS + MBSR, sham tDCS + MBSR |
Primary outcome
Change in cognitive and memory function
Time frame: Baseline, Approximately 10-14 weeks after baseline
Cognitive and memory function measured by a neuropsychological battery examining memory, executive functioning and attention
4 secondary outcomes
Change in depressive symptoms
Time frame: Baseline, Approximately 10-14 weeks after baseline
Change in anxiety symptoms
Time frame: Baseline, Approximately 10-14 weeks after baseline
Change in quality of life
Time frame: Baseline, Approximately 10-14 weeks after baseline
Change in mindfulness
Time frame: Baseline, Approximately 10-14 weeks after baseline
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 6 Jan 2020.
- Derived from this study: PubMed 34630733Brooks H, Oughli HA, Kamel L, Subramanian S, Morgan G, Blumberger DM, Kloeckner J, Kumar S, Mulsant BH, Lenze EJ, Rajji TK. Enhancing Cognition in Older Persons with Depression or Anxiety with a Combination of Mindfulness-Based Stress Reduction (MBSR) and Transcranial Direct Current Stimulation (tDCS): Results of a Pilot Randomized Clinical Trial. Mindfulness (N Y). 2021;12(12):3047-3059. doi: 10.1007/s12671-021-01764-9. Epub 2021 Oct 5.
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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.
Tarek Rajji principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS and MBSR in people with Anxiety Disorders and Mood Disorders, run by Centre for Addiction and Mental Health 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 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: finished, as of the sponsor's last update on 6 Jan 2020. 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. 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?
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 cognitive and memory function (time frame: Baseline, Approximately 10-14 weeks after baseline). 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 NCT03680664, which also lists 1 linked publication.
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 6 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.