DepressionTMSNCT02123485
The Antidepressive Effect of rTMS as add-on to ECT
A study testing Low frequency (1 hz) rTMS, as add-on to ECT in people with Depression, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the present study is to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Low frequency (1 hz) rTMS, as add-on to ECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2015to 1 Jul 2019
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the Psychiatric Hospital of Aarhus
- Patients referred for ECT
- Age 18-80 years
- Moderate or severely depressed patients (ICD-10(DSM-IV)
- HAM-D score (17-item) ≥20 and/or Ham-D subscale ≥10.
Who cannot join
- Organic brain disease
- Epilepsy or disposition to epilepsy
- Metallic objects in chest or brain
- Cardiac pacemaker
- Somatic diseases associated with brain dysfunction
- Pregnancy
Show all 10Show fewer
- Severe agitation or delirium
- Alcohol or drug dependence (ICD-10)
- Use of coercive measures
- The patient does not wish to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Antidepressant Efficacy of Repetitive Transcranial Magnetic Stimulation ( rTMS) as add-on to Electroconvulsive Therapy (ECT). A Double Blind Randomized Controlled Trial.
The aim of the present study is to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .
To investigate the correlation between blood concentration of specific inflammation makers and change in depressive symptoms during treatment
Read the detailed description
ECT is a well-established and effective method for the treatment of severe depression. During the last decades, rTMS has appeared as a potential new non-invasive antidepressant method, which may be a potential alternative to ECT due to fewer side effects.
Both methods expose the brain to an electric current. But while ECT is associated with global cerebral stimulation elicited by an epileptic seizure, rTMS implies non-convulsive focal stimulation through a time varying magnetic field. Thus, the antidepressant effect of rTMS does not depend on seizure activity and consequently requires no anesthesia. In addition, rTMS seems not to be associated with cognitive disturbances.
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex (1-4). Few have used right prefrontal low frequency rTMS, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation (5-10). Both models have been used with varying results. Meta-analysis of the antidepressant effect of rTMS (11,x) have found a modest, statistically significant antidepressant effect but generally definite conclusions on the antidepressant effect of rTMS has been difficult to draw, probably because of small and selected study populations, varying ways of stimulation and other confounding factors in the clinical setting.
The important clinical question of whether rTMS may substitute ECT in the treatment of depression has almost exclusively been elucidated in studies using high frequency stimulation of the left frontal cortex. Some of these suggest that the effectiveness of rTMS is equal to that of ECT in non-delusional patients (12-19). However, a recent investigation has compared the antidepressant efficacy and side effects of right prefrontal low frequency rTMS with ECT. In this study the mean Hamilton total 17-item (HAM-D score) scores were reduced significantly over time in both groups (ECT: p<0.001, rTMS: p<0.001); but ECT was more effective than rTMS on a short term after 3 weeks of treatment. The outcome did not point to right frontal low frequency rTMS as a first line substitute for ECT, but it might have place in the treatment of depression as add on to other types of treatment.
ECT is normally administered 3 times a week for 3-4 weeks. Daily treatment sessions might accelerate remission, but is impossible because of cognitive side effects. However, rTMS seems not to be associated with reduction in cognitive performance and might potentiate the antidepressant efficacy of ECT. Therefore the investigators have found it clinical interesting to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .
In addition we want to investigate te correlation between change in depressive symptoms and
-blood concentration of specific inflammation CNS- makers
- Conditions
- Depression
- Being tested
- Low frequency (1 hz) rTMS, as add-on to ECT, Sham-rTMS
- Keywords
- Depression,, ECT,, rTMS,, Right prefrontal,, antidepressive efficacy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency (1 hz) rTMS, as add-on to ECTDevice
Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
Sham-rTMSDevice
Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
| Study group | Role | What they receive |
|---|---|---|
| low frequency rTMS | Experimental | Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week Receives: Device: Low frequency (1 hz) rTMS, as add-on to ECT |
| Sham-rTMS | Sham comparator | Sham right prefrontal rTMS 2 times a week Receives: Device: Sham-rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score < 8.
Measured: 7 weeks
Secondary outcomes (1)
Response
The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcome. Response is defined by a reduction in the Hamilton 17 item score of >= 50%
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study start1 Apr 2015
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Why it stopped: recruiting of patients difficult combined by lack of money
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.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poul Erik Buchholtz, University of Aarhus
- Investigators
- Poul Erik Buchholtz, MD, Principal investigator, Poul Erik Buchholtz, MD Telephone: 004578472109 Email: poulhans@rm.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123485
- Sponsor's protocol ID
- 1-10-72-509-12
- Acronym
- TMS
- Status last verified
- Feb 2021
- First submitted
- 13 Mar 2014
- Last updated
- 23 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antidepressant Efficacy of Repetitive Transcranial Magnetic Stimulation ( rTMS) as add-on to Electroconvulsive Therapy (ECT). A Double Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02123485
- Acronym / sponsor ID
- TMS / 1-10-72-509-12
- Conditions
- Depression
- Keywords
- Depression,, ECT,, rTMS,, Right prefrontal,, antidepressive efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruiting of patients difficult combined by lack of money
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 23 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .
To investigate the correlation between blood concentration of specific inflammation makers and change in depressive symptoms during treatment
Detailed description
ECT is a well-established and effective method for the treatment of severe depression. During the last decades, rTMS has appeared as a potential new non-invasive antidepressant method, which may be a potential alternative to ECT due to fewer side effects.
Both methods expose the brain to an electric current. But while ECT is associated with global cerebral stimulation elicited by an epileptic seizure, rTMS implies non-convulsive focal stimulation through a time varying magnetic field. Thus, the antidepressant effect of rTMS does not depend on seizure activity and consequently requires no anesthesia. In addition, rTMS seems not to be associated with cognitive disturbances.
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex (1-4). Few have used right prefrontal low frequency rTMS, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation (5-10). Both models have been used with varying results. Meta-analysis of the antidepressant effect of rTMS (11,x) have found a modest, statistically significant antidepressant effect but generally definite conclusions on the antidepressant effect of rTMS has been difficult to draw, probably because of small and selected study populations, varying ways of stimulation and other confounding factors in the clinical setting.
The important clinical question of whether rTMS may substitute ECT in the treatment of depression has almost exclusively been elucidated in studies using high frequency stimulation of the left frontal cortex. Some of these suggest that the effectiveness of rTMS is equal to that of ECT in non-delusional patients (12-19). However, a recent investigation has compared the antidepressant efficacy and side effects of right prefrontal low frequency rTMS with ECT. In this study the mean Hamilton total 17-item (HAM-D score) scores were reduced significantly over time in both groups (ECT: p<0.001, rTMS: p<0.001); but ECT was more effective than rTMS on a short term after 3 weeks of treatment. The outcome did not point to right frontal low frequency rTMS as a first line substitute for ECT, but it might have place in the treatment of depression as add on to other types of treatment.
ECT is normally administered 3 times a week for 3-4 weeks. Daily treatment sessions might accelerate remission, but is impossible because of cognitive side effects. However, rTMS seems not to be associated with reduction in cognitive performance and might potentiate the antidepressant efficacy of ECT. Therefore the investigators have found it clinical interesting to investigate in which degree low frequency right prefrontal rTMS used ad add-on may potentiate the antidepressant effect of unilateral ECT and accelerate remission .
In addition we want to investigate te correlation between change in depressive symptoms and
-blood concentration of specific inflammation CNS- makers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low frequency rTMS | Experimental | Device: Low frequency (1 hz) rTMS, as add-on to ECTRight prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation, administered with 2 sessions each week |
| Sham-rTMS | Sham comparator | Device: Sham-rTMSSham right prefrontal rTMS 2 times a week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients admitted to the Psychiatric Hospital of Aarhus
- Patients referred for ECT
- Age 18-80 years
- Moderate or severely depressed patients (ICD-10(DSM-IV)
- HAM-D score (17-item) ≥20 and/or Ham-D subscale ≥10.
Key exclusion criteria (10 listed)
- Organic brain disease
- Epilepsy or disposition to epilepsy
- Metallic objects in chest or brain
- Cardiac pacemaker
- Somatic diseases associated with brain dysfunction
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 |
|---|---|---|
| Low frequency (1 hz) rTMS, as add-on to ECTRight prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT. | Device | low frequency rTMS |
| Sham-rTMSRight prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT. | Device | Sham-rTMS |
Primary outcome
Remission
Time frame: 7 weeks
The Hamilton (17 -item) Rating Scale for Depression is a clinician-administered assessement scale, that contains 17 items pertaining to symptoms of depression experienced over the past week. The total range is 0-52.Higher scores mean a worse outcomeRemission is defined by a Hamilton 17-item total score < 8.
1 secondary outcome
Response
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Poul Erik Buchholtz, MD principal investigator
Poul Erik Buchholtz, MD Telephone: 004578472109 Email: poulhans@rm.dk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency (1 hz) rTMS, as add-on to ECT in people with Depression, run by University of Aarhus at 1 site in Denmark.
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 10 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: stopped early, as of the sponsor's last update on 23 Feb 2021. 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 Denmark. 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. Some participants in this study may receive a placebo. 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 23 Feb 2021). 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?
Remission (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2021.