Depressive DisorderNCT00622947
The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham
A study testing right temporal low frequency (1 hz) rTMS in people with Depressive Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- right temporal low frequency (1 hz) rTMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Feb 2010
- 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
- Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
- Moderate - severe depression according to ICD-10/ DSM-IVR
- Age 18-80 years
- Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
- Right handed
Who cannot join
- Organic brain disease
- Epilepsy in growing age
- Metallic objects as the result of a chest or Brain surgery
- Cardiac pacemakers
- Somatic diseases associated with brain dysfunction
- Pregnancy
Show all 10Show fewer
- Suicide risk of severe degree
- Severe agitation or delirium
- Alcohol and drug dependency
- Ongoing Electroconvulsive treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham: A Clinical Controlled, Randomized, Blinded Study
The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.
Read the detailed description
TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients.
Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain.
Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity.
Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity.
There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms.
The investigators want to test the hypothesis that low frequency rTMS of the right temporal subcortical areas (Hippocampus and and the parahippocampal part of CNS) may perform an antidepressant effect by normalizing the described hyperactivity of the subcortical areas in depressed patients.
In addition the investigators want to test whether blood concentration of Brain Derived Neurotropic Factor( BDNF), the BDNF-genotype and saliva cortisol may be of predictive value in depressed patients.
- Conditions
- Depressive Disorder
- Being tested
- right temporal low frequency (1 hz) rTMS, Sham-rTMS
- Keywords
- Depression, antidepressant effect, rTMS, sham, cognition, saliva cortisol, brain derived neurotropic factor
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
right temporal low frequency (1 hz) rTMSProcedure or surgery
Also called A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used.
Right temporal low frequency (1 hz) rTMS.
Sham-rTMSProcedure or surgery
The coil is angled 90 degrees away from the scalp
| Study group | Role | What they receive |
|---|---|---|
| repetitive transcranial magnetic stimulation | Active comparator | Low frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval. Receives: Procedure: right temporal low frequency (1 hz) rTMS |
| Placebo stimulation | Sham comparator | Sham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval. Receives: Procedure: Sham-rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total 17-item score on the Hamilton scale for depression
semistructured interview scale.
Measured: 4 weeks of treatment and 4 weeks of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Too few patients included
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 Depressive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Poul Erik B Hansen, consultant, Principal investigator, University Hospital og Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622947
- Sponsor's protocol ID
- M-20070144
- Status last verified
- Mar 2019
- First submitted
- 24 Jan 2008
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Klein E, Kreinin I, Chistyakov A, Koren D, Mecz L, Marmur S, Ben-Shachar D, Feinsod M. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: a double-blind controlled study. Arch Gen Psychiatry. 1999 Apr;56(4):315-20. doi: 10.1001/archpsyc.56.4.315.
PubMed 10197825
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Antidepressant Effect of Right Temporal Kow Frequency rTMS Compared to Sham: A Clinical Controlled, Randomized, Blinded Study
- ClinicalTrials.gov ID
- NCT00622947
- Acronym / sponsor ID
- M-20070144
- Conditions
- Depressive Disorder
- Keywords
- Depression, antidepressant effect, rTMS, sham, cognition, saliva cortisol, brain derived neurotropic factor
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too few patients included
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Feb 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.
The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.
Detailed description
TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients.
Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain.
Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity.
Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity.
There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms.
The investigators want to test the hypothesis that low frequency rTMS of the right temporal subcortical areas (Hippocampus and and the parahippocampal part of CNS) may perform an antidepressant effect by normalizing the described hyperactivity of the subcortical areas in depressed patients.
In addition the investigators want to test whether blood concentration of Brain Derived Neurotropic Factor( BDNF), the BDNF-genotype and saliva cortisol may be of predictive value in depressed patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| repetitive transcranial magnetic stimulation | Active comparator | Procedure: right temporal low frequency (1 hz) rTMSLow frequency ( 1 HZ) rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval. |
| Placebo stimulation | Sham comparator | Procedure: Sham-rTMSSham- rTMS of the right prefrontal cortex. On each of 15 consecutive week days (apart from weekends), the patients received two 60-second1-Hz trains delivered at an intensity of 110% of motor thresholdand with a 180 seconds' intertrain interval. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
- Moderate - severe depression according to ICD-10/ DSM-IVR
- Age 18-80 years
- Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
- Right handed
Key exclusion criteria (10 listed)
- Organic brain disease
- Epilepsy in growing age
- Metallic objects as the result of a chest or Brain surgery
- Cardiac pacemakers
- 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 |
|---|---|---|
| right temporal low frequency (1 hz) rTMSAlso: A Magstim Rapid stimulator (the Magstim Company Ltd, Whiteland, UK)with a 90 mm circular coil is used.Right temporal low frequency (1 hz) rTMS. | Procedure or surgery | repetitive transcranial magnetic stimulation |
| Sham-rTMSThe coil is angled 90 degrees away from the scalp | Procedure or surgery | Placebo stimulation |
Primary outcome
The total 17-item score on the Hamilton scale for depression
Time frame: 4 weeks of treatment and 4 weeks of follow-up
semistructured interview scale.
Results and safety
The study was stopped early (reason given: Too few patients included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Background: PubMed 10197825Klein E, Kreinin I, Chistyakov A, Koren D, Mecz L, Marmur S, Ben-Shachar D, Feinsod M. Therapeutic efficacy of right prefrontal slow repetitive transcranial magnetic stimulation in major depression: a double-blind controlled study. Arch Gen Psychiatry. 1999 Apr;56(4):315-20. doi: 10.1001/archpsyc.56.4.315.
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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 B Hansen, consultant principal investigator
University Hospital og Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing right temporal low frequency (1 hz) rTMS in people with Depressive Disorder, 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 15 Mar 2019. 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?
The study was stopped early (reason given: Too few patients included). Results are not available in the source record.
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 total 17-item score on the Hamilton scale for depression (time frame: 4 weeks of treatment and 4 weeks of follow-up). 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 NCT00622947, 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 15 Mar 2019; AzTrials last refreshed its copy on 30 Oct 2026.