Clinical trial NCT00770783: Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
Official title: Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2008-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Clinical improvement (Hamilton Rating Scale for Depression)
timeFrame: After each treatment and at followups up to 3 months after the treatment course
Secondary outcomes:
measure: Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
timeFrame: After each treatment and at followups up to 3 months after the treatment course
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry and Psychotherapy - University Hospital
Study officials:
affiliation: University Hospital, Bonn
name: Thomas E. Schlaepfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.