Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.
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|ClinicalTrials.gov Identifier: NCT01748708|
Recruitment Status : Withdrawn (The protocol has undergone significant changes and the investigator feels that it is reasonable to submit a new protocol for review and approval.)
First Posted : December 12, 2012
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder||Device: Magnetic seizure therapy Device: Electroconvulsive therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Evaluating the Efficacy of Magnetic Seizure Therapy in Treatment Resistant Depression.|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
|Experimental: Magnetic seizure therapy||
Device: Magnetic seizure therapy
100% machine output at 100 Hz, with coil directed over frontal brain regions, until adequate seizure achieved. Treatments will be administered 3 times per week, up to a maximum of 15 treatments. If subjects fail to achieve the pre-defined criteria of remission at that point, they will be considered non-remitters and will exit the study.
Other Name: MagPro MST (Tonica Elektronik A/S, Denmark)
|Active Comparator: Electroconvulsive therapy||
Device: Electroconvulsive therapy
ECT treatments will be administered 3 times per week using the MECTA spECTrum 5000Q. Subjects will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 6 times the seizure threshold, up to a maximum of 15 treatments. If subjects fail to achieve the pre-defined criteria of remission at that point, they will be considered non-remitters and will exit the study.
Other Name: MECTA spECTrum 5000Q
- Hamilton Rating Scale for Depression, 24-item (HRSD-24) [ Time Frame: Change from baseline in HRSD-24 score at date of symptom remission or date of the 15th treatment, whichever comes first, assessed up to 6 months. ]The HRSD-24 is a semi-structured, clinician-administered scale used to assessed the severity of depressive symptoms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748708
|Centre for Addiction and Mental Health|
|Toronto, Ontario, Canada, M6J 1H4|
|Principal Investigator:||Z. Jeffrey Daskalakis, MD, PhD.||Centre for Addiction and Mental Health|