Treatment Resistant DepressionPhase 2MSTNCT00808938
A Pilot Study of the Use of Magnetic Seizure Therapy for Depression
A Phase 2 study testing MST in people with Treatment Resistant Depression, run by Bayside Health at 1 site in Australia.
Trial summary
Electro convulsive therapy (ECT) remains the only established therapy for the large percentage of patients with depression who fail to respond to standard treatments. It is commonly used but has substantial problems including the occurrence of cognitive side effects that are often highly distressing for patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- MST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a DSM-IV diagnosis of a major depressive episode
- Are referred for or an outpatient course of ECT at the Alfred Hospital
- Age 18-75
- Have a Montgomery-Asberg Depression Rating Scale (MADRS) score of > 25 (moderate - severe depression)
- Demonstration of capacity to give informed consent: this will be assessed by the study psychiatrist as well as the patient's primary treating psychiatrist.
Who cannot join
- Have an unstable medical condition, or neurological disorder or are currently pregnant or lactating.
- Patients not considered sufficiently well to undergo general anaesthesia for any reason
- Patients with cardiac pacemakers, cochlear implants or other implanted electronic devices. Patients with non-electric metallic implants will also be excluded.
- Significant concurrent axis 1 or 11 psychiatric comorbidity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Use of Magnetic Seizure Therapy for Treatment Resistant Depression
Electro convulsive therapy (ECT) remains the only established therapy for the large percentage of patients with depression who fail to respond to standard treatments. It is commonly used but has substantial problems including the occurrence of cognitive side effects that are often highly distressing for patients. The development of a new treatment with similar efficacy but which minimises these side effects would have great clinical value. One highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to produce similar clinical effects but without the disabling cognitive side effects related to ECT. However, substantive trials using the newest MST equipment are required. Due to the rarity of the equipment available so far, these are only being undertaken in a handful of places internationally and no research with MST has occurred in Australia. The investigators are fortunate to have been able to obtain one of the very limited number of MST devices available internationally and are proposing a pilot study of this technique. Conduct of a successful pilot study would be strong justification for an application for a large head-to-head MST - ECT comparison trial. Should MST be shown to have similar efficacy to ECT but with reduced side-effects, it is envisioned that it could rapidly replace ECT in clinical practice throughout Australia and indeed internationally with substantial ongoing benefits to patients. These would include enhanced use of it as an outpatient therapy as well as the reduction in side-effects.
The study will be an open label trial of MST in 15 patients with treatment resistant depression who have been referred for ECT. All patients will undergo a dose titration procedure to establish seizure threshold, six MST treatment sessions will then be provided at 120% of threshold. If the patients have not achieved a 50% reduction in their depressive symptoms (as measured by the Montgomery Asberg Depression Rating Scale rating scale) patients will receive another 12 sessions. MST will be administered three times a week. Patients will undergo a series of assessments to determine both the efficacy of MST and the cognitive outcomes. The primary outcome measure will be the MADRS measure of depression severity. The investigators will additionally measure patient rated depression severity and cognitive functioning The overall aim of the current project is to, via an open label pilot trial, investigate the clinical response to magnetic seizure therapy in patients with treatment resistant depression who have been referred for electroconvulsive therapy.
- Conditions
- Treatment Resistant Depression
- Being tested
- MST
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSTDevice
Magnetic Seizure Therapy
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Not described Receives: Device: MST |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Measured: 2 weeks
Secondary outcomes (1)
Cognitive Assessment
Measured: 2 - 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionJan 2011
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 Treatment Resistant 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808938
- Sponsor's protocol ID
- 28508
- Acronym
- MST
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Fitzgerald PB, Hoy KE, Herring SE, Clinton AM, Downey G, Daskalakis ZJ. Pilot study of the clinical and cognitive effects of high-frequency magnetic seizure therapy in major depressive disorder. Depress Anxiety. 2013 Feb;30(2):129-36. doi: 10.1002/da.22005. Epub 2012 Oct 18.
PubMed 23080404
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Use of Magnetic Seizure Therapy for Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT00808938
- Acronym / sponsor ID
- MST / 28508
- Conditions
- Treatment Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bayside HealthOther government
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 16 Dec 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.
Electro convulsive therapy (ECT) remains the only established therapy for the large percentage of patients with depression who fail to respond to standard treatments. It is commonly used but has substantial problems including the occurrence of cognitive side effects that are often highly distressing for patients. The development of a new treatment with similar efficacy but which minimises these side effects would have great clinical value. One highly promising possibility is magnetic seizure therapy (MST). MST involves replacing the electrical stimulation used in ECT with a magnetic stimulus. This appears to be able to produce similar clinical effects but without the disabling cognitive side effects related to ECT. However, substantive trials using the newest MST equipment are required. Due to the rarity of the equipment available so far, these are only being undertaken in a handful of places internationally and no research with MST has occurred in Australia. The investigators are fortunate to have been able to obtain one of the very limited number of MST devices available internationally and are proposing a pilot study of this technique. Conduct of a successful pilot study would be strong justification for an application for a large head-to-head MST - ECT comparison trial. Should MST be shown to have similar efficacy to ECT but with reduced side-effects, it is envisioned that it could rapidly replace ECT in clinical practice throughout Australia and indeed internationally with substantial ongoing benefits to patients. These would include enhanced use of it as an outpatient therapy as well as the reduction in side-effects.
The study will be an open label trial of MST in 15 patients with treatment resistant depression who have been referred for ECT. All patients will undergo a dose titration procedure to establish seizure threshold, six MST treatment sessions will then be provided at 120% of threshold. If the patients have not achieved a 50% reduction in their depressive symptoms (as measured by the Montgomery Asberg Depression Rating Scale rating scale) patients will receive another 12 sessions. MST will be administered three times a week. Patients will undergo a series of assessments to determine both the efficacy of MST and the cognitive outcomes. The primary outcome measure will be the MADRS measure of depression severity. The investigators will additionally measure patient rated depression severity and cognitive functioning The overall aim of the current project is to, via an open label pilot trial, investigate the clinical response to magnetic seizure therapy in patients with treatment resistant depression who have been referred for electroconvulsive therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Device: MST |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a DSM-IV diagnosis of a major depressive episode
- Are referred for or an outpatient course of ECT at the Alfred Hospital
- Age 18-75
- Have a Montgomery-Asberg Depression Rating Scale (MADRS) score of > 25 (moderate - severe depression)
- Demonstration of capacity to give informed consent: this will be assessed by the study psychiatrist as well as the patient's primary treating psychiatrist.
Key exclusion criteria (4 listed)
- Have an unstable medical condition, or neurological disorder or are currently pregnant or lactating.
- Patients not considered sufficiently well to undergo general anaesthesia for any reason
- Patients with cardiac pacemakers, cochlear implants or other implanted electronic devices. Patients with non-electric metallic implants will also be excluded.
- Significant concurrent axis 1 or 11 psychiatric comorbidity.
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 |
|---|---|---|
| MSTMagnetic Seizure Therapy | Device | Active Treatment |
Primary outcome
MADRS
Time frame: 2 weeks
1 secondary outcome
Cognitive Assessment
Time frame: 2 - 6 weeks
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 13 Feb 2013.
- Derived from this study: PubMed 23080404Fitzgerald PB, Hoy KE, Herring SE, Clinton AM, Downey G, Daskalakis ZJ. Pilot study of the clinical and cognitive effects of high-frequency magnetic seizure therapy in major depressive disorder. Depress Anxiety. 2013 Feb;30(2):129-36. doi: 10.1002/da.22005. Epub 2012 Oct 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MST in people with Treatment Resistant Depression, run by Bayside Health at 1 site in Australia.
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 5 inclusion and 4 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 13 Feb 2013. 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 Australia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
MADRS (time frame: 2 weeks). 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 NCT00808938, 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 13 Feb 2013.