DepressionNCT02966106
The Antidepressant Efficacy of Low Frequency rTMS as add-on
A study testing Right prefrontal low frequency rTMS in people with Depression, run by University of Aarhus.
Trial summary
rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). Research on rTMS reports of minimal side effects of the method . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Right prefrontal low frequency rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2017
- 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
- Out-patients referred to Aarhus University Hospital, Risskov
- Moderate-severe uni- and bipolar depression according to ICD-10
- Age 18-80 years
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 Antidepressive Effect of Low Frequency Right Prefrontal Repetitive Transcranial Magnetic Stimulation as add-on to Antidepressant Drug Treatment. A Blinded, Placebo Controlled Randomised Study.
rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). Research on rTMS reports of minimal side effects of the method . The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex .
Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation .Both stimulus models has been shown to have statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.
Read the detailed description
rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive 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). To some extent, this differential effect of different frequencies is reflected in human studies (REF).
The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex , which has been approved by the USA FDA (1) and later in EU for the treatment of depression.
Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation . In addition low frequency rTMS is generally less time-consuming. Both stimulus models has been shown to have a modest, statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. The issue indicates that low frequency due to the more advantagous side effect profile should be the stimulus model of choice in a clinical setting.
Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.
- Conditions
- Depression
- Being tested
- Right prefrontal low frequency rTMS, Sham-rTMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right prefrontal low frequency rTMSDevice
A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval
Sham-rTMSOther
Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval
| Study group | Role | What they receive |
|---|---|---|
| Right prefrontal low frequency rTMS. | Active comparator | Right prefrontal low frequency rTMS (1Hz). A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval Receives: Device: Right prefrontal low frequency rTMS |
| Sham-rTMS | Placebo comparator | Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval Receives: Other: Sham-rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
remission
the number of patients obtaining a Hamilton-17 item total score of < 8
Measured: 8 weeks
Secondary outcomes (2)
Response
the number of patients obtaining a reduction in the 17-item score on the Hamilton scale for depression of >= 50%
Measured: 8 weeks
Cognitive function
Psychological testing of cognitive functions
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: The study design was not compatible with recruiting patients to the investigation
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poul Erik Buchholtz, MD, Principal investigator, Aarhus University Hospital, Risskov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966106
- Sponsor's protocol ID
- AMB-TMS-16
- Status last verified
- Nov 2016
- First submitted
- 15 Nov 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antidepressive Effect of Low Frequency Right Prefrontal Repetitive Transcranial Magnetic Stimulation as add-on to Antidepressant Drug Treatment. A Blinded, Placebo Controlled Randomised Study.
- ClinicalTrials.gov ID
- NCT02966106
- Acronym / sponsor ID
- AMB-TMS-16
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study design was not compatible with recruiting patients to the investigation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Nov 2016 (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.
rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the brain through a time varying magnetic field. ). Research on rTMS reports of minimal side effects of the method . The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex .
Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation .Both stimulus models has been shown to have statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.
Detailed description
rTMS has appeared a potential new non-invasive antidepressant method, which implies non-convulsive 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). To some extent, this differential effect of different frequencies is reflected in human studies (REF).
The majority of clinically controlled studies have used high frequency stimulation of the left frontal cortex , which has been approved by the USA FDA (1) and later in EU for the treatment of depression.
Fewer studies have used right prefrontal, which has less side effects, such as local discomfort and a lower risk of releasing epileptic seizures, than high frequency stimulation . In addition low frequency rTMS is generally less time-consuming. Both stimulus models has been shown to have a modest, statistically significant antidepressant effect and recent research clearly indicates that low frequency rTMS of the right prefrontal cortex i associated with an antidepressant effect at the same level as the high frequency model. The issue indicates that low frequency due to the more advantagous side effect profile should be the stimulus model of choice in a clinical setting.
Therefore the investigators want to examine the antidepressant effect of a specific rTMS low frequency model in a clinical setting using a placebo controlled, randomized double blind design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right prefrontal low frequency rTMS. | Active comparator | Device: Right prefrontal low frequency rTMSRight prefrontal low frequency rTMS (1Hz). A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval |
| Sham-rTMS | Placebo comparator | Other: Sham-rTMSRight prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Out-patients referred to Aarhus University Hospital, Risskov
- Moderate-severe uni- and bipolar depression according to ICD-10
- Age 18-80 years
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 |
|---|---|---|
| Right prefrontal low frequency rTMSA treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval | Device | Right prefrontal low frequency rTMS. |
| Sham-rTMSRight prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval | Other | Sham-rTMS |
Primary outcome
remission
Time frame: 8 weeks
the number of patients obtaining a Hamilton-17 item total score of < 8
2 secondary outcomes
Response
Time frame: 8 weeks
Cognitive function
Time frame: 8 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 29 Nov 2017.
- 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
Aarhus University Hospital, Risskov
Questions about this trial
What is this clinical trial studying?
A study testing Right prefrontal low frequency rTMS 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 3 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 29 Nov 2017. 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. 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?
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?
remission (time frame: 8 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 29 Nov 2017.