This trial is active, not recruiting.

Condition major depression
Treatments thymatron, tonica magpro mst
Phase phase 3
Sponsor University Hospital, Bonn
Start date February 2005
End date September 2013
Trial size 30 participants
Trial identifier NCT00770783, BSG-05-001


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
tonica magpro mst
100% power, vertex placement, 3 times per week for 4 weeks
(Active Comparator)
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks

Primary Outcomes

Clinical improvement (Hamilton Rating Scale for Depression)
time frame: After each treatment and at followups up to 3 months after the treatment course

Secondary Outcomes

Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
time frame: After each treatment and at followups up to 3 months after the treatment course

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
Principal investigator Thomas E. Schlaepfer, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by University Hospital, Bonn.