Major Depressive DisorderNCT01198561
Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression
An observational study of Major Depressive Disorder, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2006to Dec 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with major depressive disorder, who were not responsive to antidepressants
Who may be able to join
- Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
- Antidepressant medication will be maintained throughout the study period.
Who cannot join
- Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
- To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Kangnam-Ku, 135-710
Doh Kwan Kim, M.D., Ph.D., 82-2-3410-3582, paulkim@skku.edu
Doh Kwan Kim, M.D., Ph.D.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism
The objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.
Read the detailed description
The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.
- Conditions
- Major Depressive Disorder
- Being tested
- repetitive Transcranial Magnetic Stimulation
- Keywords
- repetitive Transcranial Magnetic Stimulation, Major Depressive Disorder
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive Transcranial Magnetic StimulationDevice
10 times repetitive TMS, high frequency
| Study group | Role | What they receive |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation | repetitive Transcranial Magnetic Stimulation is a depressive patient group treated with rTMS Receives: Device: repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton depression rating scale (HAM-D 17)
measuring instrument of severity of depressive symptoms
Measured: baseline, 1, 2, and 4 weeks after TMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startFeb 2006
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doh Kwan Kim, Samsung Medical Center
- Investigators
- Doh K KIm, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01198561
- Sponsor's protocol ID
- 2005-08-072
- Status last verified
- Dec 2015
- First submitted
- 8 Sep 2010
- Last updated
- 31 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation(rTMS) in the Treatment of Depression : Effect of TMS on Depression, Cognitive Function, and Regional Cerebral Glucose Metabolism
- ClinicalTrials.gov ID
- NCT01198561
- Acronym / sponsor ID
- 2005-08-072
- Conditions
- Major Depressive Disorder
- Keywords
- repetitive Transcranial Magnetic Stimulation, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Sep 2010 (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 objective of this study is to investigate the antidepressant efficacy of rTMS, and to assess cortical metabolism before and after rTMS sessions in patients with major depression. We also aimed to investigate differences between the responders and nonresponders to rTMS and what would predict clinical response to rTMS.
Detailed description
The specific aims of this study is to: (1) evaluate the antidepressant efficacy of rTMS on major depression; (2) evaluate the effects of rTMS on cognitive function in depressive patients; (3) assess the effects of rTMS on cerebral glucose metabolism in depressive patients as measured by 18FDG PET; (4) investigate the differences of the regional cerebral glucose uptake changes during rTMS between responders and nonresponders to rTMS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| repetitive Transcranial Magnetic Stimulation | – | Device: repetitive Transcranial Magnetic Stimulationrepetitive Transcranial Magnetic Stimulation is a depressive patient group treated with rTMS |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with major depressive disorder, who were not responsive to antidepressants
Key inclusion criteria (2 listed)
- Twenty patients fulfilling the diagnostic criteria of major depression according to DSM IV will be enrolled in the study.
- Antidepressant medication will be maintained throughout the study period.
Key exclusion criteria (2 listed)
- Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
- To exclude the effect of drug changes on post-rTMS cerebral glucose metabolism, the combinations and dosage of pre-rTMS antidepressant drugs will remain unchanged until the post-rTMS 18FDG PET is done.
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 Stimulation10 times repetitive TMS, high frequency | Device | repetitive Transcranial Magnetic Stimulation |
Primary outcome
Hamilton depression rating scale (HAM-D 17)
Time frame: baseline, 1, 2, and 4 weeks after TMS
measuring instrument of severity of depressive symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2015.
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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.
Doh K KIm, Ph.D principal investigator
Samsung Medical Center
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 Major Depressive Disorder, run by Samsung Medical Center at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 31 Dec 2015. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doh Kwan Kim, M.D., Ph.D. (82-2-3410-3582, paulkim@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton depression rating scale (HAM-D 17) (time frame: baseline, 1, 2, and 4 weeks after TMS). 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 31 Dec 2015.