DepressionNCT01318018
Investigation on the Value of Bilateral Index (BIS) Monitoring for Magnetic Seizure Versus Electroconvulsive Therapy
An observational study of Depression, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Feb 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from depression
Who may be able to join
- depression
Who cannot join
- age < 18 years old
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Anaesthesiology and Intensive Care Medicine & Dept. of Psychiatry and Psychotherapy, University of Bonn Hospital
Bonn
About this study
Official title: Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression
Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of its antidepressant potency but may be associated with less severe cognitive side effects.
Control of anaesthesia during seizure therapy is demanding since light anesthesia might be associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor anaesthesia for ECT, however little is known about BIS following MST.
The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster increase in BIS and that (b)less left-right differences occur in BIS.
- Conditions
- Depression
- Keywords
- depression, bispectral index, electroconvulsive therapy, magnetic seizure therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure Therapy Group | Patients receiving magnetic seizure therapy for depression | |
| Electroconvulsive Therapy Group | Patients receiving electroconvulsive therapy for depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery Time
recovery time from seizure induction to eye opening / restoration of breathing
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Soehle, University Hospital, Bonn
- Investigators
- Martin Soehle, MD, PhD, Principal investigator, Dept of Anaesthesiology and Intensive Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318018
- Sponsor's protocol ID
- KTB
- Status last verified
- Dec 2017
- First submitted
- 17 Mar 2011
- Last updated
- 5 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Soehle M, Kayser S, Ellerkmann RK, Schlaepfer TE. Bilateral bispectral index monitoring during and after electroconvulsive therapy compared with magnetic seizure therapy for treatment-resistant depression. Br J Anaesth. 2014 Apr;112(4):695-702. doi: 10.1093/bja/aet410. Epub 2013 Dec 3.
PubMed 24305645Jiang 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 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Bispectral Index Monitoring During and After Electroconvulsive Therapy Compared With Magnetic Seizure Therapy for Treatment-resistant Depression
- ClinicalTrials.gov ID
- NCT01318018
- Acronym / sponsor ID
- KTB
- Conditions
- Depression
- Keywords
- depression, bispectral index, electroconvulsive therapy, magnetic seizure therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Posted 5 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Electroconvulsive therapy (ECT) has been shown to be an effective treatment for patients suffering from depression, who do not respond to medical treatment. However it is often dismissed by patients, who feel uncomfortably about the application of electric shocks to their heads. In 2000, magnetic seizure therapy (MST) has been introduced which uses magnetism instead of electricity to evoke convulsions. MST seems to be as effective as ECT in terms of its antidepressant potency but may be associated with less severe cognitive side effects.
Control of anaesthesia during seizure therapy is demanding since light anesthesia might be associated with awareness, whereas deep anesthesia impedes the antidepressant effect of the convulsion. Therefore, Bispectral index (BIS) monitoring is frequently used to tailor anaesthesia for ECT, however little is known about BIS following MST.
The investigators hypothesize that in comparing MST with ECT, (a) patients show a faster increase in BIS and that (b)less left-right differences occur in BIS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure Therapy Group | – | –Patients receiving magnetic seizure therapy for depression |
| Electroconvulsive Therapy Group | – | –Patients receiving electroconvulsive therapy for depression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from depression
Key inclusion criteria (1 listed)
- depression
Key exclusion criteria (2 listed)
- age < 18 years old
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recovery Time
Time frame: same day
recovery time from seizure induction to eye opening / restoration of breathing
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24305645Soehle M, Kayser S, Ellerkmann RK, Schlaepfer TE. Bilateral bispectral index monitoring during and after electroconvulsive therapy compared with magnetic seizure therapy for treatment-resistant depression. Br J Anaesth. 2014 Apr;112(4):695-702. doi: 10.1093/bja/aet410. Epub 2013 Dec 3.
- 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.
- Individual participant dataSharing planned: No
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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.
Martin Soehle, MD, PhD principal investigator
Dept of Anaesthesiology and Intensive Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 2 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 5 Oct 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recovery Time (time frame: same day). 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 NCT01318018, which also lists 2 linked publications.
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 5 Oct 2018.