Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
This study is currently recruiting participants.
Verified April 2013 by University Hospital, Bonn
Sponsor:
University Hospital, Bonn
Information provided by (Responsible Party):
Thomas E. Schlaepfer, MD, University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00770783
First received: October 9, 2008
Last updated: April 15, 2013
Last verified: April 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
Device: Thymatron Device: Tonica MagPro MST |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bonn:
Primary Outcome Measures:
- Clinical improvement (Hamilton Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical improvement (Montgomery- Åsberg Rating Scale for Depression) [ Time Frame: After each treatment and at followups up to 3 months after the treatment course ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2005 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Magnetic Seizure Therapy (MST) |
Device: Tonica MagPro MST
100% power, vertex placement, 3 times per week for 4 weeks
|
| Active Comparator: Electroconvulsive Therapy (ECT) |
Device: Thymatron
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770783
Contacts
| Contact: Sarah Kayser, MD | +49 228 287 15025 | Sarah.Kayser@ukb.uni-bonn.de |
Locations
| Germany | |
| Department of Psychiatry and Psychotherapy - University Hospital | Recruiting |
| Bonn, Germany, 53105 | |
| Contact: Sarah Kayser, MD +49 228 287 15715 sarah.kayser@ukb.uni-bonn.de | |
Sponsors and Collaborators
University Hospital, Bonn
Investigators
| Principal Investigator: | Thomas E. Schlaepfer, MD | University Hospital, Bonn |
More Information
No publications provided
| Responsible Party: | Thomas E. Schlaepfer, MD, Professor of Psychiatry and Psychotherapy, University Hospital, Bonn |
| ClinicalTrials.gov Identifier: | NCT00770783 History of Changes |
| Other Study ID Numbers: | BSG-05-001 |
| Study First Received: | October 9, 2008 |
| Last Updated: | April 15, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013