DepressionNCT03868774
The Antidepressant Effect of Right Prefrontal Low Frequency rTMS in an Accelerated Treatment Model
A study testing repetitive transcranial magnetic stimulation in people with Depression, run by University of Aarhus.
Trial summary
Repetitive transcranial magnetic stimulation has appeared a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- repetitive transcranial magnetic stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2019
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-severe uni- and bipolar depression according to the International Classification of Diseases (ICD-10)
- A Hamilton scale score (HDS-17) of ≥ 18 and/or a sub-scale (HDSS) score of ≥ 9 within 24-48 hours before the first treatment
Who cannot join
- Organic brain disease.
- Epileptic seizure < 2 years
- Patients with implanted metal parts in the brain or chest
- Patients with pacemaker
- Medical diseases with cerebral impact
- Serious suicidal danger
About this study
Official title: The Antidepressant Effect of Right Prefrontal Low Frequency rTMS in an Accelerated Treatment Model ( rTMS). An Open Controlled, Randomized Study
Repetitive transcranial magnetic stimulation has appeared a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field. The method is associated with minimal side effects limited to local discomfort and especially no impact on cognitive function. The method has been approved for the treatment of depression in Canada, USA and a couple of European countries. The department for Affective Disorders, Aarhus University Hospital has used rTMS as add-on to conventional antidepressant treatment in the outpatient clinic since 2015. A single treatment course covers 20 sessions given on 20 consecutive days. The demand for daily treatment and attendance for 20 days is resource demanding for both the patient and the clinic. In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the outcome of the standard model ( 20 days) with a treatment model covering the same number of stimuli given within one week.
Read the detailed description
rTMS has appeared a potential new non-invasive antidepressant method, which implies nonconvulsive focal stimulation of the brain through a time varying magnetic field. RTMS is based on the principle of electromagnetism. An electromagnetic coil placed on the scalp produces a time-varying magnetic field that penetrates the scalp and skull unattenuated and gives rise to a current in the proximity of the cerebral cortex as well as functionally connected parts of the brain. Research on rTMS reports of minimal side effects of the method.
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The stimulus frequency has shown to play a key role in the mechanisms of action of rTMS. Previous animal studies have shown that low frequency rTMS is associated with long term inhibition of neuronal activity (long term depression), while high frequency stimulation is followed by prolonged activation (long term potentiation). The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex, which has been approved by the USA and later in the European Union for the treatment of depression. Fewer studies 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. Randomized controlled trials and meta-analysis have shown that both stimulus models have a clinically, significant antidepressant effect at the same level as antidepressant drugs, and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex is associated with an antidepressant effect at the same level as the high frequency model. The issue indicates that low frequency due to the more advantageous side effect profile should be the stimulus model of choice in a clinical setting.
The Department for Affective Disorders, Aarhus University Hospital has taken part in rTMS research since 1999, and the outpatient clinic has used low frequency rTMS as add-on to conventional antidepressant treatment since 2015. A single treatment course covers 20 treatment sessions given on 20 consecutive days. The demand for daily treatment and attendance in the outpatient clinic for 20 days is resource demanding both for the patient and the clinic. In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the antidepressant efficacy of conventional treatment (20 days) with a treatment model covering the same number of stimuli given within one week.The study is lightening the significance of the association between the number of stimulus pulses, the length of the total treatment period and the antidepressant effect. Patients suffering for depression may benefit from the outcome of the study by obtaining an accelerated antidepressant effect from a less time consuming stimulus model. The outcome of the study may be implemented in clinical practice from day one.
- Conditions
- Depression
- Being tested
- repetitive transcranial magnetic stimulation
- Keywords
- treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulationProcedure or surgery
rTMS is a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| rTMS standard | Active comparator | Low frequency (1 Hz), rTMS 20 sessions given on 20 consecutive days ( except weekends) Receives: Procedure: repetitive transcranial magnetic stimulation |
| rTMS accelerated model | Active comparator | Low frequency ( 1 Hz), right prefrontal transcranial magnetic stimulation. 20 sessions given on 5 consecutive days ( 4 sessions each day) Receives: Procedure: repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hamilton 17 item scale score for depression
A semistructured interview. On the basis of a systematic registration of well defined depressive symptoms through the preceding 3 days a total 17 item score and af 6-item subscale score expressing the degree of depression is calculated. The score is positively correlated to the degree af depression, Remission is defined as a total score after termination of treatment of >= 8, response is defined by >= 50% decrease in the total 17 item score during the treatment period
Measured: up to 4 weeks
Secondary outcomes (1)
cognitive function
Neuropsychological test of cognitive functions
Measured: 1 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study startSep 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Lack of ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- comparing the antidepressant effect of a standard rTMS model with an accelerated treatment model
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 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, Department of Depression and Anxiety
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868774
- Sponsor's protocol ID
- ADA
- Status last verified
- Aug 2019
- First submitted
- 7 Mar 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antidepressant Effect of Right Prefrontal Low Frequency rTMS in an Accelerated Treatment Model ( rTMS). An Open Controlled, Randomized Study
- ClinicalTrials.gov ID
- NCT03868774
- Acronym / sponsor ID
- ADA
- Conditions
- Depression
- Keywords
- treatment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Mar 2019 (actual)
- 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.
Repetitive transcranial magnetic stimulation has appeared a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field. The method is associated with minimal side effects limited to local discomfort and especially no impact on cognitive function. The method has been approved for the treatment of depression in Canada, USA and a couple of European countries. The department for Affective Disorders, Aarhus University Hospital has used rTMS as add-on to conventional antidepressant treatment in the outpatient clinic since 2015. A single treatment course covers 20 sessions given on 20 consecutive days. The demand for daily treatment and attendance for 20 days is resource demanding for both the patient and the clinic. In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the outcome of the standard model ( 20 days) with a treatment model covering the same number of stimuli given within one week.
Detailed description
rTMS has appeared a potential new non-invasive antidepressant method, which implies nonconvulsive focal stimulation of the brain through a time varying magnetic field. RTMS is based on the principle of electromagnetism. An electromagnetic coil placed on the scalp produces a time-varying magnetic field that penetrates the scalp and skull unattenuated and gives rise to a current in the proximity of the cerebral cortex as well as functionally connected parts of the brain. Research on rTMS reports of minimal side effects of the method.
Previous research indicates that the antidepressant effect of rTMS is associated with specific stimulation of the dorsolateral prefrontal cortex. The stimulus frequency has shown to play a key role in the mechanisms of action of rTMS. Previous animal studies have shown that low frequency rTMS is associated with long term inhibition of neuronal activity (long term depression), while high frequency stimulation is followed by prolonged activation (long term potentiation). The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex, which has been approved by the USA and later in the European Union for the treatment of depression. Fewer studies 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. Randomized controlled trials and meta-analysis have shown that both stimulus models have a clinically, significant antidepressant effect at the same level as antidepressant drugs, and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex is associated with an antidepressant effect at the same level as the high frequency model. The issue indicates that low frequency due to the more advantageous side effect profile should be the stimulus model of choice in a clinical setting.
The Department for Affective Disorders, Aarhus University Hospital has taken part in rTMS research since 1999, and the outpatient clinic has used low frequency rTMS as add-on to conventional antidepressant treatment since 2015. A single treatment course covers 20 treatment sessions given on 20 consecutive days. The demand for daily treatment and attendance in the outpatient clinic for 20 days is resource demanding both for the patient and the clinic. In consequence the investigators want to examine the antidepressant effect of an accelerated stimulus model comparing the antidepressant efficacy of conventional treatment (20 days) with a treatment model covering the same number of stimuli given within one week.The study is lightening the significance of the association between the number of stimulus pulses, the length of the total treatment period and the antidepressant effect. Patients suffering for depression may benefit from the outcome of the study by obtaining an accelerated antidepressant effect from a less time consuming stimulus model. The outcome of the study may be implemented in clinical practice from day one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- comparing the antidepressant effect of a standard rTMS model with an accelerated treatment model
| Arm | Type | Receives |
|---|---|---|
| rTMS standard | Active comparator | Procedure: repetitive transcranial magnetic stimulationLow frequency (1 Hz), rTMS 20 sessions given on 20 consecutive days ( except weekends) |
| rTMS accelerated model | Active comparator | Procedure: repetitive transcranial magnetic stimulationLow frequency ( 1 Hz), right prefrontal transcranial magnetic stimulation. 20 sessions given on 5 consecutive days ( 4 sessions each day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate-severe uni- and bipolar depression according to the International Classification of Diseases (ICD-10)
- A Hamilton scale score (HDS-17) of ≥ 18 and/or a sub-scale (HDSS) score of ≥ 9 within 24-48 hours before the first treatment
Key exclusion criteria (6 listed)
- Organic brain disease.
- Epileptic seizure < 2 years
- Patients with implanted metal parts in the brain or chest
- Patients with pacemaker
- Medical diseases with cerebral impact
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 |
|---|---|---|
| repetitive transcranial magnetic stimulationrTMS is a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field. | Procedure or surgery | rTMS accelerated model, rTMS standard |
Primary outcome
The Hamilton 17 item scale score for depression
Time frame: up to 4 weeks
A semistructured interview. On the basis of a systematic registration of well defined depressive symptoms through the preceding 3 days a total 17 item score and af 6-item subscale score expressing the degree of depression is calculated. The score is positively correlated to the degree af depression, Remission is defined as a total score after termination of treatment of >= 8, response is defined by >= 50% decrease in the total 17 item score during the treatment period
1 secondary outcome
cognitive function
Time frame: 1 and 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- 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
Department of Depression and Anxiety
Questions about this trial
What is this clinical trial studying?
A study testing repetitive transcranial magnetic stimulation in people with Depression, run by University of Aarhus.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The Hamilton 17 item scale score for depression (time frame: up to 4 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 19 Aug 2019.