Major Depressive DiorderNCT02348411
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Bilateral Anterior Capsulotomy in the Treatment of Medication-Refractory MDD
A study testing ExAblate in people with Major Depressive Diorder, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory MDD, using the ExAblate transcranial system. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Major Depressive Diorder
- What is being tested?
- ExAblate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Aug 2015to 23 Jul 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, between 20 and 65 years, inclusive
- Diagnosed with nonpsychotic major depressive disorder, single or recurrent episode by DSM-IV-TR Diagnosis of Diagnostic and Statistical Manual of Mental Disorder fourth edition(DSM-IV) MDD as confirmed from clinical history and examination by psychiatrist.
- Subjects who are able and willing to give consent and able to attend all study visits
- Proof of Refractoriness
- In current episode:
- Depression refractory to adequate trials of medication (Persistence of the major depressive episode to a minimum of 3 adequate depression treatments from at least 3 different treatment categories - SSRIs, TCAs, other antidepressants, lithium addition, irreversible MAO inhibitor, etc.)
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- Documented resistance to ECT (at least 6 sessions or <6 treatments if there is clear evidence of inability to tolerate more, or refused, or withdrew consent after ECT was recommended.
- Proof of chronicity
- More than 5 years after first episode of MDD
- current episode of ≥24-mo duration \&/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥12 mos)
- Proof of Severity
- HAMD-17 score≥20
- Global Assessment of Function Score<50
- Designated Ablation Targets can be target by the ExAblate device. Designated Ablation Targets must be apparent on MRI such that targeting can be performed with direct visualization
- Able to communicate sensations during the ExAblate MRgFUS treatment
- Depression medication regimen is stable for at least 30 days before enrollment
Who cannot join
- Subjects with current or previous diagnosis of following psychotic or bipolar disorders:
- Subjects has primary or serious(requiring additional treatment) comorbid obsessive compulsive disorder, posttraumatic stress disorder, panic disorder, bulimia, or anorexia in the last year by DSM-IV
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse(aside nicotine) as defined by the criteria outlined in the DSM-IV occurring within a 12 months period
- Active suicidal ideation with plan or intent for self harm and made suicide attempt within the past 12 months
- Patient meets criteria for personality disorder in the last 12 months by DSM-IV
- Patients with unstable cardiac status including:
Show all 46Show fewer
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
- Severely impaired renal function (estimated glomerular filtration rate < 45ml/min/1.73 m2) or receiving dialysis
- Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
- Known intolerance or allergies to the MRI contrast agent(e.g. Gadolinium or Magnevist) including advanced kidney disease
- History of abnormal bleeding and/or coagulopathy
- Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure
- Active or suspected acute or chronic uncontrolled infection
- History of intracranial hemorrhage
- Cerebrovascular disease (multiple CVA or CVA within 6 months)
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hrs of total table time.)
- Symptoms and signs of increased intracranial pressue (e.g. headache, nausea, vomiting, lethargy, and papilledema)
- Are participating or have participated in another clinical trial in the last 30 days
- Unable to communicate with the investigator and staff.
- Presence of any other neurodegenerative disease like Parkinson-plus syndromes suspected on neurological examination. These included:
- Multisystem atrophy
- Progressive supranuclear palsy
- Dementia with Lewy bodies
- Alzheimer's disease
- Anyone suspected to have the diagnosis of MDD. This includes: psychotic depression, bipolar I or II disorder, mental disorder due to organic factors.
- Presence of significant cognitive impairment as determined with a score ≤ 24 on the Mini Mental Status Examination (MMSE)
- History of immunocompromise, including patient who is HIV positive
- Known life-threatening systemic disease
- Patients with a history of seizures within the past year
- For the purpose of this study, we consider a significant mood disorder to include any patient who has:
- received transcranial magnetic stimulation
- received electroconvulsive therapy
- Patients with risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter, PT > 14, PTT > 36 or INR > 1.3) or a documented coagulopathy
- Patients with any types of brain tumors, including metastases.
- Any illness that in the investigator's opinion preclude participation in this study.
- Pregnancy or lactation.
- Legal incapacity or limited legal capacity.
- Patients who have had deep brain stimulation or a prior stereotactic ablation of the Designated Ablation Target.
- Prior intracranial surgery
- Calcifications in the sonication pathway that cannot be avoided by tailoring the treatment plan
- More than 30% of the scalp in the sonication pathway is covered by scars, scalp disorders (e.g., eczema) or atrophy of the scalp
- Clips or other metallic implanted objects in the sonication pathway, except shunts.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Neurosurgery, Yonsei University College of Medicine
Seoul, 120752
About this study
The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory MDD, using the ExAblate transcranial system.
The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. For MDD Patients: one or more thermal lesion will be created on Bilateral Anterior Limb of internal Capsule.
Read more
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of target to be treated. The ExAblate computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.
The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing 1000-element phased array transducer) positioned above the subject head. The ExAblate transcranial system also includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation.
After informed consent and screening, eligible subjects will proceed to the treatment. All subjects will be followed at Day 1, 7 days, 1 month , and 6 months . At follow up visits, patients will be evaluated for general health, neurological changes (including MMSE exam),and efficacy measurements as well as for device/procedure related adverse events that may have occurred during the follow-up period. Six (6) month follow up visit will also include Full Battery Cognitive/Neurological Testing
- Conditions
- Major Depressive Diorder
- Being tested
- ExAblate
- Keywords
- Medication-refractory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblateDevice
Also called Treatment with the ExAblate Transcranial MRgFUS System
| Study group | Role | What they receive |
|---|---|---|
| ExAblate Treatment group | Experimental | Not described Receives: Device: ExAblate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess Hamilton Depression Rating Scale-17
Measured: 6 months
Secondary outcomes (1)
To assess adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start27 Aug 2015
- Primary completion23 Jul 2018
- Study completion23 Jul 2018
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 Major Depressive DiorderStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348411
- Sponsor's protocol ID
- 1-2014-0073
- Status last verified
- Feb 2019
- First submitted
- 21 Jan 2015
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim M, Kim CH, Jung HH, Kim SJ, Chang JW. Treatment of Major Depressive Disorder via Magnetic Resonance-Guided Focused Ultrasound Surgery. Biol Psychiatry. 2018 Jan 1;83(1):e17-e18. doi: 10.1016/j.biopsych.2017.05.008. Epub 2017 May 12. No abstract available.
PubMed 28601192
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Bilateral Anterior Capsulotomy in the Treatment of Medication-Refractory MDD
- ClinicalTrials.gov ID
- NCT02348411
- Acronym / sponsor ID
- 1-2014-0073
- Conditions
- Major Depressive Diorder
- Keywords
- Medication-refractory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 23 Jul 2018 (actual)
- First posted
- 28 Jan 2015 (estimated)
- 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 purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided focused ultrasound thermal ablation of a designated area in the brain of patients suffering from medication-refractory MDD, using the ExAblate transcranial system.
The ExAblate system is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. For MDD Patients: one or more thermal lesion will be created on Bilateral Anterior Limb of internal Capsule.
The treatment begins with a series of standard diagnostic MR images to identify the location and shape of target to be treated. The ExAblate computer uses the physician's designation of the target volume to plan the best way to cover the target volume with small spots called "sonications". These treatment spots are cylinder shaped. Their size depends on sonication power and duration. During the treatment, a specific MR scan, which can be processed to identify changes in tissue temperature, provides a thermal map of the treatment volume to confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress, and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.
The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing 1000-element phased array transducer) positioned above the subject head. The ExAblate transcranial system also includes means to immobilize the subject head, cool the interface water, and software for CT analysis and phase correction computation.
After informed consent and screening, eligible subjects will proceed to the treatment. All subjects will be followed at Day 1, 7 days, 1 month , and 6 months . At follow up visits, patients will be evaluated for general health, neurological changes (including MMSE exam),and efficacy measurements as well as for device/procedure related adverse events that may have occurred during the follow-up period. Six (6) month follow up visit will also include Full Battery Cognitive/Neurological Testing
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate Treatment group | Experimental | Device: ExAblate |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men and women, between 20 and 65 years, inclusive
- Diagnosed with nonpsychotic major depressive disorder, single or recurrent episode by DSM-IV-TR Diagnosis of Diagnostic and Statistical Manual of Mental Disorder fourth edition(DSM-IV) MDD as confirmed from clinical history and examination by psychiatrist.
- Subjects who are able and willing to give consent and able to attend all study visits
- Proof of Refractoriness
- Depression refractory to adequate trials of medication (Persistence of the major depressive episode to a minimum of 3 adequate depression treatments from at least 3 different treatment categories - SSRIs, TCAs, other antidepressants, lithium addition, irreversible MAO inhibitor, etc.)
Key exclusion criteria (46 listed)
- Subjects with current or previous diagnosis of following psychotic or bipolar disorders:
- Subjects has primary or serious(requiring additional treatment) comorbid obsessive compulsive disorder, posttraumatic stress disorder, panic disorder, bulimia, or anorexia in the last year by DSM-IV
- Patients exhibiting any behavior(s) consistent with ethanol or substance abuse(aside nicotine) as defined by the criteria outlined in the DSM-IV occurring within a 12 months period
- Active suicidal ideation with plan or intent for self harm and made suicide attempt within the past 12 months
- Patient meets criteria for personality disorder in the last 12 months by DSM-IV
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 |
|---|---|---|
| ExAblateAlso: Treatment with the ExAblate Transcranial MRgFUS System | Device | ExAblate Treatment group |
Primary outcome
To assess Hamilton Depression Rating Scale-17
Time frame: 6 months
1 secondary outcome
To assess adverse events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 28601192Kim M, Kim CH, Jung HH, Kim SJ, Chang JW. Treatment of Major Depressive Disorder via Magnetic Resonance-Guided Focused Ultrasound Surgery. Biol Psychiatry. 2018 Jan 1;83(1):e17-e18. doi: 10.1016/j.biopsych.2017.05.008. Epub 2017 May 12. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate in people with Major Depressive Diorder, run by Yonsei University at 1 site in South Korea.
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 16 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. 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 South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess Hamilton Depression Rating Scale-17 (time frame: 6 months). 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 NCT02348411, 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 15 Feb 2019.