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Magnetic Seizure Therapy for Depression (CREST-MST Trial)
N/A
Waitlist Available
Led By Daniel Blumberger, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
are 18 years of age or older
Patients must be 18 years of age or older
Must not have
Patients with any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm
Patients with a concomitant major unstable medical illness
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 weeks
Awards & highlights
Summary
This trial is testing Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression.
Who is the study for?
This trial is for adults with non-psychotic Major Depressive Disorder who haven't responded well to medications. They must be able to consent, follow the treatment schedule, and women of childbearing age need a negative pregnancy test. Excluded are those not fluent in English, with sensory impairments, recent substance abuse, major medical illnesses or conditions affecting mood/cognition (like hypothyroidism), pregnant women, primary psychotic disorders or PTSD as main issues.
What is being tested?
The study compares Magnetic Seizure Therapy (MST) with Electroconvulsive Therapy (ECT) for treating severe depression. The goal is to see if MST can be an effective alternative to ECT by providing better response rates and tolerability for patients resistant to medication.
What are the potential side effects?
While specific side effects aren't listed here, both MST and ECT may cause confusion or memory problems shortly after treatment. There could also be headaches or muscle soreness following therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any major brain disorders or conditions that could increase pressure in my skull.
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I do not have any major unstable illnesses.
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I don't take more than 2 mg/day of lorazepam or its equivalent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24)
Secondary study objectives
Improvement in symptom severity of Suicidal Ideation as measured by the Scale for Suicidal Ideation (SSI)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Magnetic Seizure Therapy (MST)Experimental Treatment1 Intervention
MST treatments will be administered using the MagPro MST with Cool TwinCoil.
Group II: Electroconvulsive Therapy (ECT)Active Control1 Intervention
ECT treatments will be administered using the MECTA spECTrum 5000Q or the MECTA Sigma devices.
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthOTHER
366 Previous Clinical Trials
82,117 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,317 Total Patients Enrolled
University of California, San DiegoOTHER
1,157 Previous Clinical Trials
1,571,200 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your initial HRSD-24 score is 21 or higher.I am deemed suitable for convulsive therapy by a psychiatrist and an anesthesiologist.I do not have any major brain disorders or conditions that could increase pressure in my skull.You have a medical condition, take a medication, or have a lab test result that could cause significant memory or mood problems, according to the study doctor.You will be included if your baseline HRSD-24 score is 21 or higher.You have been diagnosed with substance dependence or abuse in the last three months.You have been diagnosed with a primary psychotic disorder.My main diagnosis is OCD or PTSD, which affects me more than my depression.I am currently receiving medical care, either staying in the hospital or visiting as an outpatient.I am willing and able to agree to treatment and research as confirmed by my psychiatrist.I am 18 years old or older.I am currently receiving medical care, either staying in the hospital or visiting.You have been diagnosed with non-psychotic major depressive disorder using the MINI-6.0 interview.I am 18 years old or older.I am deemed suitable for convulsive therapy by both a psychiatrist and an anesthesiologist.You must have a HRSD-24 score of 21 or higher at the beginning of the study.I agree to not change my current antidepressant medication during the study.I am willing and able to agree to treatment and research procedures.I do not have any major unstable illnesses.The study investigator thinks you might have dementia.You have been diagnosed with non-psychotic major depressive disorder using the MINI International Neuropsychiatric Interview, Version 6.I don't take more than 2 mg/day of lorazepam or its equivalent.You have a significant hearing or vision problem that can't be fixed and might make it hard for you to do the tests.Patients must meet the safety criteria set by the MST.You have a metal object in your head that can't be safely removed.
Research Study Groups:
This trial has the following groups:- Group 1: Electroconvulsive Therapy (ECT)
- Group 2: Magnetic Seizure Therapy (MST)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT03191058 — N/A
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