Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression
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|ClinicalTrials.gov Identifier: NCT03421574|
Recruitment Status : Recruiting
First Posted : February 5, 2018
Last Update Posted : July 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: MR-guided Focused Ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Major Depression|
|Actual Study Start Date :||January 19, 2018|
|Estimated Primary Completion Date :||December 7, 2020|
|Estimated Study Completion Date :||December 7, 2020|
|Experimental: MR-Guided Focused Ultrasound||
Device: MR-guided Focused Ultrasound
Focused Ultrasound allows for non-invasive thermal ablation of soft tissue virtually anywhere in the body. Treatment begins by acquiring a series of magnetic resonance (MR) images of the target tissue. The physician then reviews the images on the system workstation, identifies the target, delineates treatment contours, and reviews the treatment plan. Therapy planning software calculates the parameters required to effectively treat (e.g. ablate) the defined region. During treatment, the patient wears a helmet equipped with multiple sources of ultrasound which generate a point of focused energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, causing a thermal coagulation effect.
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]Safety of the ExAblate transcranial treatment will be determined by an evaluation of the incidence and severity of procedure related complications from the treatment day visit through the 12-month post-treatment time point. All events that are not procedure related will also be captured and recorded.
- Quality of Life will be measured using the Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) [ Time Frame: 1 year ]Q-LES-Q) is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70.
- Clinical efficacy will be measured using the Hamilton Rating Scale for Depression (HAMD) [ Time Frame: 1 year ]
The HAMD is designed to rate the severity of depression in patients. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression
≥ 23 = Very Severe Depression
- Clinical efficacy will be measured using the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 year ]The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Higher scores indicate increasing depressive symptoms. Ratings can be added to form an overall score (range 0 to 50); no weights are used. Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
- Clinical efficacy will be measured using the Beck Depression Inventory (BDI) [ Time Frame: 1 year ]BDI is a self-rated depression scale. 1-10:These ups and downs are considered normal;11-16: Mild mood disturbance; 17-20: Borderline clinical depression; 21-30: Moderate depression; 31-40: Severe depression; over 40: Extreme depression.
- Clinical efficacy will be measured using the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 1 year ]C-SSRS is a suicidal ideation rating scale created by researchers at Columbia University to evaluate suicidality in children ages 12 and up. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03421574
|Contact: Sachie Sharma, PhD||416-480-6100 ext email@example.com|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Anusha Baskaran, PhD 416-480-6100 ext 1650 firstname.lastname@example.org|