Depressive Disorder, MajorNCT06110585
Transcranial Magnetic Stimulation in Patients With Depression and Non-suicidal Self-injury
A study testing Transcranial Magnetic Stimulation (TMS) in people with Depressive Disorder, Major and Self-Injurious Behavior, run by Brain Institute of Rio Grande do Sul at 1 site in Brazil.
Trial summary
This clinical trial aims to investigate the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adult patients with depression and non-suicidal self-injury (NSSI). Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Depressive Disorder, Major, Self-Injurious Behavior
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2023to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current diagnosis of major depressive disorder by the operational criteria of DSM-5 and non-suicidal self-injury behavior, defined by "engagement in and intentionally self-inflicted harm to the surface of one's body, likely resulting in bleeding, bruising, or pain (e.g., cutting, burning, puncturing, hitting, excessive rubbing), with the expectation that the injury will only lead to minor or moderate physical harm (i.e., no suicidal intent)". (at least one episode in the past year);
- Depression severity score ≥17 points (moderate depression criteria) on the 17-item Hamilton Depression Rating Scale (HAM-D-17);
- Currently receiving psychiatric treatment and/or engaged in psychotherapy with a minimum biweekly frequency;
- Consent to voluntary participation in the study, confirmed by signing the Informed Consent Form;
- Expressed willingness to comply with all study procedures, including imaging examinations and blood tests, with availability during the study, and to communicate with the study team regarding adverse events and other clinically important information;
- Commitment to access continuous psychiatric care before and after study completion;
- In good general health, as evidenced by medical history.
Who cannot join
- Participants who present pre-established contraindications for undergoing EMT, based on positive responses in the "TMS Adult Safety Screen (TASS)" questionnaire, such as: cochlear implants, brain stimulators (DBS), electrode implants or aneurysm clips, history of previous seizures, use of pacemakers, presence of implantable defibrillators, brain injury (whether vascular, neoplastic, traumatic, infectious, or metabolic);
- Patients who present a moderate to severe suicide risk, as determined by clinical evaluation or requiring psychiatric hospitalization during the recruitment or EMT application period;
- Patients with severe clinical comorbidities or any other reason that impedes self-mobility, preventing attendance at daily EMT sessions;
- Pregnant patients or those of childbearing age who are sexually active without using contraceptive methods.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Cérebro do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90610-000
Karoline Flach, +555133205900
About this study
Official title: Transcranial Magnetic Stimulation: Evaluation of Improvement of Transdiagnostic Psychiatric Symptoms and Changes in Functional Neuroiming in Young Adults Patients With Major Depressive Disorder and Non-suicidal Self-injury
This clinical trial aims to investigate the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adult patients with depression and non-suicidal self-injury (NSSI).
The main questions this study aims to answer are:
Read more
- Does adjunctive TMS reduce psychiatric symptoms in young adults with major depressive disorder and non-suicidal self-injury?
- Does adjunctive TMS cause any changes in neuroimaging markers in young adults with major depressive disorder and non-suicidal self-injury?
- Does adjunctive TMS cause any effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury?
Participants in this study will undergo an extensive clinical evaluation, functional neuroimaging tests (MRI and fNIRS), and peripheral blood collection. They will be randomly assigned to one of two interventions: (1) 20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol, or (2) 20 sham sessions using a placebo procedure with the TMS equipment. After the 20 sessions, additional clinical assessments, neuroimaging and blood tests will be conducted. The data analysis will compare the two groups in terms of response and remission of internalizing and externalizing psychiatric symptoms, as well as neuroimaging and blood tests outcomes.
Read the detailed description
This comprehensive clinical trial seeks to explore the potential therapeutic benefits of Transcranial Magnetic Stimulation (TMS) when used as an adjunctive treatment for young adult patients grappling with both depression and non-suicidal self-injury (NSSI). The overarching objectives of this study are multifaceted and aim to address critical questions regarding the efficacy and underlying mechanisms of TMS in this particular demographic.
The primary research inquiries guiding this investigation are:
Psychiatric Symptom Reduction: Does the incorporation of adjunctive TMS lead to a significant reduction in psychiatric symptoms among young adults diagnosed with major depressive disorder and non-suicidal self-injury?
Neuroimaging Markers: Does adjunctive TMS induce any discernible changes in neuroimaging markers among young adults with major depressive disorder and non-suicidal self-injury? This involves employing sophisticated functional neuroimaging techniques such as MRI (Magnetic Resonance Imaging) and fNIRS (functional Near-Infrared Spectroscopy).
Blood Biomarkers: Are there observable effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury following adjunctive TMS treatment?
To investigate these questions, participants enrolled in the study will undergo an extensive and thorough clinical evaluation. Additionally, functional neuroimaging tests, encompassing both MRI and fNIRS, will be administered to gain insights into the neural correlates of TMS treatment. Furthermore, peripheral blood samples will be collected to analyze potential changes in blood biomarkers associated with TMS.
The study design incorporates a randomized assignment of participants to one of two interventions:
Active TMS Intervention: Participants will undergo 20 sessions of TMS utilizing the intermittent theta burst stimulation (iTBS) protocol.
Sham TMS Intervention: A control group will receive 20 sham sessions involving a placebo procedure with the TMS equipment.
Following the completion of the intervention phase, participants will undergo additional clinical assessments, neuroimaging, and blood tests to comprehensively evaluate the impact of TMS treatment. The subsequent data analysis will involve a rigorous comparison of the two groups, assessing factors such as the response and remission of internalizing and externalizing psychiatric symptoms, as well as outcomes related to neuroimaging and blood tests.
- Being tested
- Transcranial Magnetic Stimulation (TMS), Sham
- Medical subject headings
- Depressive Disorder, Major, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Procedure or surgery
The Intermittent Theta Burst Stimulation (iTBS) protocol will be used. This protocol involves bursts of stimulation at the theta frequency range, approximately 5 to 8 Hz. The specific combination utilized combines bursts of pulses at a frequency of 50 Hz, triggered at a rate of 5 Hz. Thus, a burst of 3 pulses is delivered with intervals of 20 ms between them, and this burst is repeated at intervals of 200 ms (i.e., 5 bursts per second). Every second, 15 pulses are delivered.
ShamProcedure or surgery
A stimulator with an arm containing a non-functional replica of the stimulation coil will be utilized. The application procedures will be identical to those of the active group, except that the device simulating the stimulation coil will not generate a magnetic field, only producing sound cues mimicking a stimulus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: rTMS Treatment | Experimental | 20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol Receives: Procedure: Transcranial Magnetic Stimulation (TMS) |
| Sham Comparator: Sham Treatment | Sham comparator | 20 sham sessions using a placebo procedure with the TMS equipment. Receives: Procedure: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale
Proportion of individuals with a 50% or more score reduction between before and after intervention
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Patient Health Questionnaire-9
Proportion of individuals with a 50% or more score reduction between before and after intervention
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Montgomery-Asberg Depression Rating Scale
Proportion of individuals with a 50% or more score reduction between before and after intervention
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
fMRI assessed neural network connectivity
Change on functional connectivity
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
fMRI-assessed resting connectivity
Change (e.g. normalization) of baseline network-level deficits.
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Secondary outcomes (9)
Functional Assessment of Self-Mutilation (FASM)
Difference in score between before and after the intervention
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Hamilton Depression Rating Scale
Proportion of individuals with a 50% or more score reduction between before and after intervention
Measured: 1, 3 , 6 and 12 months after completion of TMS treatment
Patient Health Questionnaire-9
Proportion of individuals with a 50% or more score reduction between before and after intervention
Measured: 1, 3 , 6 and 12 months after completion of TMS treatment
Montgomery-Asberg Depression Rating Scale
Proportion of individuals with a 50% or more score reduction between before and after intervention
Measured: 1, 3 , 6 and 12 months after completion of TMS treatment
fNIRS- assessed changes in blood oxygenation levels in the brain
Changes in blood oxygenation levels in the brain measured by fNIRS (functional near-infrared spectroscopy) to infer neural activity
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Brain-Derived Neurotrophic Factor (BDNF)
Changes in BDNF levels comparing pre- and post-treatment
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Ciliary Neurotrophic Factor (CNTF)
Changes in CNTF levels comparing pre- and post-treatment
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Glial Cell-Derived Neurotrophic Factor (GDNF)
Changes in GDNF levels comparing pre- and post-treatment
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Nerve Growth Factor (NGF)
Changes in GDNF levels comparing pre- and post-treatment
Measured: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain Institute of Rio Grande do Sul
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Lucas Spanemberg, PhD, Principal investigator, Instituto do Cérebro do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110585
- Sponsor's protocol ID
- 908
- Other IDs
- INSCER908
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation: Evaluation of Improvement of Transdiagnostic Psychiatric Symptoms and Changes in Functional Neuroiming in Young Adults Patients With Major Depressive Disorder and Non-suicidal Self-injury
- ClinicalTrials.gov ID
- NCT06110585
- Acronym / sponsor ID
- 908
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brain Institute of Rio Grande do SulResearch network
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to investigate the effects of Transcranial Magnetic Stimulation (TMS) as an adjunctive treatment for young adult patients with depression and non-suicidal self-injury (NSSI).
The main questions this study aims to answer are:
- Does adjunctive TMS reduce psychiatric symptoms in young adults with major depressive disorder and non-suicidal self-injury?
- Does adjunctive TMS cause any changes in neuroimaging markers in young adults with major depressive disorder and non-suicidal self-injury?
- Does adjunctive TMS cause any effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury?
Participants in this study will undergo an extensive clinical evaluation, functional neuroimaging tests (MRI and fNIRS), and peripheral blood collection. They will be randomly assigned to one of two interventions: (1) 20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol, or (2) 20 sham sessions using a placebo procedure with the TMS equipment. After the 20 sessions, additional clinical assessments, neuroimaging and blood tests will be conducted. The data analysis will compare the two groups in terms of response and remission of internalizing and externalizing psychiatric symptoms, as well as neuroimaging and blood tests outcomes.
Detailed description
This comprehensive clinical trial seeks to explore the potential therapeutic benefits of Transcranial Magnetic Stimulation (TMS) when used as an adjunctive treatment for young adult patients grappling with both depression and non-suicidal self-injury (NSSI). The overarching objectives of this study are multifaceted and aim to address critical questions regarding the efficacy and underlying mechanisms of TMS in this particular demographic.
The primary research inquiries guiding this investigation are:
Psychiatric Symptom Reduction: Does the incorporation of adjunctive TMS lead to a significant reduction in psychiatric symptoms among young adults diagnosed with major depressive disorder and non-suicidal self-injury?
Neuroimaging Markers: Does adjunctive TMS induce any discernible changes in neuroimaging markers among young adults with major depressive disorder and non-suicidal self-injury? This involves employing sophisticated functional neuroimaging techniques such as MRI (Magnetic Resonance Imaging) and fNIRS (functional Near-Infrared Spectroscopy).
Blood Biomarkers: Are there observable effects on blood biomarkers in young adults with major depressive disorder and non-suicidal self-injury following adjunctive TMS treatment?
To investigate these questions, participants enrolled in the study will undergo an extensive and thorough clinical evaluation. Additionally, functional neuroimaging tests, encompassing both MRI and fNIRS, will be administered to gain insights into the neural correlates of TMS treatment. Furthermore, peripheral blood samples will be collected to analyze potential changes in blood biomarkers associated with TMS.
The study design incorporates a randomized assignment of participants to one of two interventions:
Active TMS Intervention: Participants will undergo 20 sessions of TMS utilizing the intermittent theta burst stimulation (iTBS) protocol.
Sham TMS Intervention: A control group will receive 20 sham sessions involving a placebo procedure with the TMS equipment.
Following the completion of the intervention phase, participants will undergo additional clinical assessments, neuroimaging, and blood tests to comprehensively evaluate the impact of TMS treatment. The subsequent data analysis will involve a rigorous comparison of the two groups, assessing factors such as the response and remission of internalizing and externalizing psychiatric symptoms, as well as outcomes related to neuroimaging and blood tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: rTMS Treatment | Experimental | Procedure: Transcranial Magnetic Stimulation (TMS)20 sessions of TMS using the intermittent theta burst stimulation (iTBS) protocol |
| Sham Comparator: Sham Treatment | Sham comparator | Procedure: Sham20 sham sessions using a placebo procedure with the TMS equipment. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Current diagnosis of major depressive disorder by the operational criteria of DSM-5 and non-suicidal self-injury behavior, defined by "engagement in and intentionally self-inflicted harm to the surface of one's body, likely resulting in bleeding, bruising, or pain (e.g., cutting, burning, puncturing, hitting, excessive rubbing), with the expectation that the injury will only lead to minor or moderate physical harm (i.e., no suicidal intent)". (at least one episode in the past year);
- Depression severity score ≥17 points (moderate depression criteria) on the 17-item Hamilton Depression Rating Scale (HAM-D-17);
- Currently receiving psychiatric treatment and/or engaged in psychotherapy with a minimum biweekly frequency;
- Consent to voluntary participation in the study, confirmed by signing the Informed Consent Form;
- Expressed willingness to comply with all study procedures, including imaging examinations and blood tests, with availability during the study, and to communicate with the study team regarding adverse events and other clinically important information;
Key exclusion criteria (4 listed)
- Participants who present pre-established contraindications for undergoing EMT, based on positive responses in the "TMS Adult Safety Screen (TASS)" questionnaire, such as: cochlear implants, brain stimulators (DBS), electrode implants or aneurysm clips, history of previous seizures, use of pacemakers, presence of implantable defibrillators, brain injury (whether vascular, neoplastic, traumatic, infectious, or metabolic);
- Patients who present a moderate to severe suicide risk, as determined by clinical evaluation or requiring psychiatric hospitalization during the recruitment or EMT application period;
- Patients with severe clinical comorbidities or any other reason that impedes self-mobility, preventing attendance at daily EMT sessions;
- Pregnant patients or those of childbearing age who are sexually active without using contraceptive methods.
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)The Intermittent Theta Burst Stimulation (iTBS) protocol will be used. This protocol involves bursts of stimulation at the theta frequency range, approximately 5 to 8 Hz. The specific combination utilized combines bursts of pulses at a frequency of 50 Hz, triggered at a rate of 5 Hz. Thus, a burst of 3 pulses is delivered with intervals of 20 ms between them, and this burst is repeated at intervals of 200 ms (i.e., 5 bursts per second). Every second, 15 pulses are delivered. | Procedure or surgery | Experimental: rTMS Treatment |
| ShamA stimulator with an arm containing a non-functional replica of the stimulation coil will be utilized. The application procedures will be identical to those of the active group, except that the device simulating the stimulation coil will not generate a magnetic field, only producing sound cues mimicking a stimulus. | Procedure or surgery | Sham Comparator: Sham Treatment |
Primary outcome
Hamilton Depression Rating Scale
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Proportion of individuals with a 50% or more score reduction between before and after intervention
Patient Health Questionnaire-9
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Proportion of individuals with a 50% or more score reduction between before and after intervention
Montgomery-Asberg Depression Rating Scale
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Proportion of individuals with a 50% or more score reduction between before and after intervention
fMRI assessed neural network connectivity
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Change on functional connectivity
fMRI-assessed resting connectivity
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Change (e.g. normalization) of baseline network-level deficits.
9 secondary outcomes
Functional Assessment of Self-Mutilation (FASM)
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Hamilton Depression Rating Scale
Time frame: 1, 3 , 6 and 12 months after completion of TMS treatment
Patient Health Questionnaire-9
Time frame: 1, 3 , 6 and 12 months after completion of TMS treatment
Montgomery-Asberg Depression Rating Scale
Time frame: 1, 3 , 6 and 12 months after completion of TMS treatment
fNIRS- assessed changes in blood oxygenation levels in the brain
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Brain-Derived Neurotrophic Factor (BDNF)
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Ciliary Neurotrophic Factor (CNTF)
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Glial Cell-Derived Neurotrophic Factor (GDNF)
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Nerve Growth Factor (NGF)
Time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Depressive Disorder, Major
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
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.
Lucas Spanemberg, PhD principal investigator
Instituto do Cérebro do Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Depressive Disorder, Major and Self-Injurious Behavior, run by Brain Institute of Rio Grande do Sul at 1 site in Brazil.
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 4 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 31 Oct 2023. 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 Brazil. 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 Lucas Spanemberg, PhD (+555133205900, lucas.spanemberg@pucrs.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (time frame: Week 1 prior to TMS treatment and week 1 after completion of TMS treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2023.