Trial of MR-guided Focused Ultrasound for Treatment of Refractory Major Depression

NCT ID: NCT03421574

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2021-07-28

Brief Summary

The proposed study is to evaluate the safety and initial efficacy of MRgFUS for patients with treatment-refractory Major Depression. This study is designed as a prospective, single arm, nonrandomized study. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life (QoL). The target in the brain chosen for ablation will be the anterior limb of the internal capsule (i.e 'capsulotomy').

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR-Guided Focused Ultrasound

Group Type: EXPERIMENTAL

MR-guided Focused Ultrasound

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Men and women ≥20 and ≤80 years of age.

2. Patients who are able and willing to give consent and physically and practically able to attend study visits, as determined by both study Psychiatrist and the surgeon.

3. DSM-V diagnosis of major depressive episode, as a component of an Axis I disorder, such as Major Depressive Disorder, Bipolar Disorder, Anxiety Disorder, Eating Disorder, Substance Abuse/Dependence Disorder ,or Personality Disorder

4. At least 5-year illness history of the primary disorder and at least 6 months since the onset of the first episode of major depression.

5. A minimum score of 20 on the Hamilton Depression Rating Scale (HAMD) when depressed (patients with bipolar disorder may be rapid cycling, but have to have at least 2 weeks of major depression at the time the HAMD is conducted)

6. Medication-refractoriness as determined by an adequate dose and duration of standard psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:

1. Failed to respond or tolerate adequate trial of three or more medications accepted as first line in the treatment of depression

2. Failed to respond or tolerate augmentation with or combination,of at least 2 medications known to be first line treatments for depression

3. An adequate trial of cognitive behavioural therapy or other evidence-supported psychotherapy, delivered by a therapist experienced in treating depression

7. Able to communicate sensations during the ExAblate MRgFUS treatment

8. A consistent dose of any and all medications in the 30 days prior to study entry.

9. Women of childbearing potential must agree to use a contraception method throughout the study.

Exclusion Criteria

1. Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP > 100 on medication)]

2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.

3. Severely impaired renal function (estimated glomerular filtration rate < 30ml/min/1.73 m2) or receiving dialysis

4. Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR)

5. Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage

6. Untreated, uncontrolled sleep apnea

7. 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

8. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment

9. Are participating or have participated in another clinical trial in the last 30 days

10. Patients unable to communicate with the investigator and staff.

11. Presence of significant cognitive impairment

12. Presence of psychosis on clinical evaluation.

13. Patients with brain tumors already known or revealed on pretreatment MRI

14. Currently pregnant (as determined by history and serum HCG) or lactating.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Nir Lipsman

Princiapl Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

344-2017

Identifier Type: -

Identifier Source: org_study_id