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Recruitment Status : Withdrawn (The protocol has undergone significant changes and the investigator feels that it is reasonable to submit a new protocol for review and approval.)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.
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): 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|