Major Depression
Conditions
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).
Interventions
DEVICEThymatron
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
DEVICETonica MagPro MST
100% power, vertex placement, 3 times per week for 4 weeks
Sponsors
University Hospital, Bonn
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical improvement (Hamilton Rating Scale for Depression) | After each treatment and at followups up to 3 months after the treatment course |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) | After each treatment and at followups up to 3 months after the treatment course |
Countries
Germany
Outcome results
None listed