Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression

Study Overview
=================
Brief Summary
-----------------
The investigators intend to test in a single center, clinical pilot efficacy study the primary hypothesis that Magnetic Seizure Therapy (MST) as add-on therapy to a controlled pharmacotherapy is efficacious in the treatment of refractory major depression assessed with the Hamilton Depression Rating Scale (HAMD).

Official Title
-----------------
Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Device: Thymatron
* Device: Tonica MagPro MST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is diagnosed with a major depressive episode (MDE) according to DSM-IV Diagnosis Criteria derived from the SCID. Patient has not had an acceptable clinical response due to failure (resistance) with at least two treatments from different treatment categories during the current MDE. Patient has a score ≥ 20 on the 24-item Hamilton Rating Scale of Depression. Patient is able to give his informed consent to participate in this study and he is able to fulfill the requirements of the study. Patient is a male or nonpregnant female adequately protected from conception. Females of childbearing potential must use an acceptable method of birth control. Convulsive therapy clinically indicated Exclusion Criteria: Patient currently has a secondary diagnosis of, or signs of, delirium, dementia, amnesia, or other cognitive disorders per DSM-IV. Patient has had or has currently a diagnosis of non-affective psychotic disorder per DSM-IV. Patient has had alcohol or substance dependence within the previous 12 months or abuse within the previous six months other than nicotine dependence or abuse. Patient has a history or diagnosis of clinically relevant cardiac disease. Patient has a history or diagnosis of clinically relevant injury or disease of the central nervous system. Patient has magnetic material in the head. Patient has implanted medical devices such as cardiac pacemaker, vagus nerve stimulator, medical pumps etc.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magnetic Seizure Therapy (MST)<br> | Device: Tonica MagPro MST<br>* 100% power, vertex placement, 3 times per week for 4 weeks<br>|
| Active Comparator: Electroconvulsive Therapy (ECT)<br> | Device: Thymatron<br>* Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement (Hamilton Rating Scale for Depression) |  | After each treatment and at followups up to 3 months after the treatment course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) |  | After each treatment and at followups up to 3 months after the treatment course |