Major DepressionPhase 3NCT00770783
Magnetic Seizure Therapy (MST) for Treatment Resistant Major Depression
A Phase 3 study testing Thymatron and Tonica MagPro MST in people with Major Depression, run by University Hospital, Bonn at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Thymatron and Tonica MagPro MST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2005to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy - University Hospital
Bonn, 53105
About this study
Official title: Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
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).
- Conditions
- Major Depression
- Being tested
- Thymatron, Tonica MagPro MST
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymatronDevice
Right unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks
Tonica MagPro MSTDevice
100% power, vertex placement, 3 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | Not described Receives: Device: Tonica MagPro MST |
| Electroconvulsive Therapy (ECT) | Active comparator | Not described Receives: Device: Thymatron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement (Hamilton Rating Scale for Depression)
Measured: After each treatment and at followups up to 3 months after the treatment course
Secondary outcomes (1)
Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
Measured: After each treatment and at followups up to 3 months after the treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startFeb 2005
- Primary completionSep 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas E. Schlaepfer, MD, University Hospital, Bonn
- Investigators
- Thomas E. Schlaepfer, MD, Principal investigator, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770783
- Sponsor's protocol ID
- BSG-05-001
- Status last verified
- Aug 2018
- First submitted
- 9 Oct 2008
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34131914
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnetic Seizure Therapy (MST) in Refractory Major Depression
- ClinicalTrials.gov ID
- NCT00770783
- Acronym / sponsor ID
- BSG-05-001
- Conditions
- Major Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Feb 2005 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | Device: Tonica MagPro MST |
| Electroconvulsive Therapy (ECT) | Active comparator | Device: Thymatron |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThymatronRight unilateral placement, 3x seizure threshold, 3 times per week for 4 weeks | Device | Electroconvulsive Therapy (ECT) |
| Tonica MagPro MST100% power, vertex placement, 3 times per week for 4 weeks | Device | Magnetic Seizure Therapy (MST) |
Primary outcome
Clinical improvement (Hamilton Rating Scale for Depression)
Time frame: After each treatment and at followups up to 3 months after the treatment course
1 secondary outcome
Clinical improvement (Montgomery- Åsberg Rating Scale for Depression)
Time frame: After each treatment and at followups up to 3 months after the treatment course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Derived from this study: PubMed 34131914Jiang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas E. Schlaepfer, MD principal investigator
University Hospital, Bonn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymatron and Tonica MagPro MST in people with Major Depression, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (Hamilton Rating Scale for Depression) (time frame: After each treatment and at followups up to 3 months after the treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.