Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (NCT03191058) | Clinical Trial Compass
CompletedNot Applicable
Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression
United States, Canada219 participantsStarted 2018-06-26
Plain-language summary
This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for depression. Even with multiple medication trials, 30 - 40% of patients will experience a pharmacologically resistant form of illness. The ineffectiveness of current treatments for major depressive disorder (MDD) coupled with the economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. are inpatients or outpatients;
✓. are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
✓. have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic MDD
✓. are 18 years of age or older
✓. have a baseline HRSD-24 score \> or = 21;
✓. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
✓. are agreeable to keeping their current antidepressant treatment constant during the intervention;
✓. are likely able to adhere to the intervention schedule;
Exclusion criteria
✕. have a history of MINI diagnosis of substance dependence or abuse within the past three months;
What they're measuring
1
Improvement in symptom severity of depression as measured by the Hamilton Rating Scale for Depression - 24 (HRSD-24)
Timeframe: 7 weeks
2
Cognitive adverse effects as indexed by the Autobiographical Memory Test (AMT)
Timeframe: 7 weeks
Trial details
NCT IDNCT03191058
SponsorUniversity of Texas Southwestern Medical Center
. have a concomitant major unstable medical illness;
✕. are pregnant or intend to get pregnant during the study;
✕. have a MINI diagnosis of any primary psychotic disorder
✕. have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
✕. have probable dementia based on study investigator assessment;
✕. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
✕. present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);