Major DepressionPhase 4NCT01325831
Changes of Functional Connectivity After rTMS in Depression
A Phase 4 study testing repetitive transcranial magnetic stimulation(rTMS) in people with Major Depression, run by Yonsei University at 1 site in South Korea.
Trial summary
In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Major Depression
- What is being tested?
- repetitive transcranial magnetic stimulation(rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Jun 2011
- Phase
- Phase 4
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV major depressive episode
- Failure of at least 3 different kind of antidepressant
Who cannot join
- Organic brain disorder
- Other diagnosis of DMS-IV except nicotine dependence
- History of seizure disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Psychiatry, Severance Hospital
Seoul, 120-752
About this study
Official title: Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
Read the detailed description
Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache.
We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS.
All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.
- Conditions
- Major Depression
- Being tested
- repetitive transcranial magnetic stimulation(rTMS), Sham repetitive transcranial magnetic stimulation(rTMS)
- 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 stimulation(rTMS)Device
Also called MAGSTIM
10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
Sham repetitive transcranial magnetic stimulation(rTMS)Device
Sham repetitive transcranial magnetic stimulation(rTMS)
| Study group | Role | What they receive |
|---|---|---|
| transcranial magnetic stimluation | Experimental | Not described Receives: Device: repetitive transcranial magnetic stimulation(rTMS) |
| rTMS_sham | Sham comparator | Not described Receives: Device: Sham repetitive transcranial magnetic stimulation(rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of functional connectivity between pre/post rTMS
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2009
- Primary completionJun 2011
- Study completionJun 2011
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 Major DepressionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EUN LEE, M.D., Ph.D., Principal investigator, Yonsei University College of Medicine, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325831
- Sponsor's protocol ID
- 4-2008-0525
- Status last verified
- Jan 2012
- First submitted
- 7 Jul 2009
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kang JI, Lee H, Jhung K, Kim KR, An SK, Yoon KJ, Kim SI, Namkoong K, Lee E. Frontostriatal Connectivity Changes in Major Depressive Disorder After Repetitive Transcranial Magnetic Stimulation: A Randomized Sham-Controlled Study. J Clin Psychiatry. 2016 Sep;77(9):e1137-e1143. doi: 10.4088/JCP.15m10110.
PubMed 27379563
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Dopamine Pathway After rTMS Treatment in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01325831
- Acronym / sponsor ID
- 4-2008-0525
- Conditions
- Major Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Mar 2011 (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.
In order to explore the effect of repetitive TMS, which has shown to be effective in intractable depression, we will examine resting-state, default-mode network functional connectivity in patients with major depression. We will use a double-blind, sham-controlled design. Our target sample size is 60(30 patients will be treated by active rTMS, the other 30 will be treated by sham rTMS). We will apply 10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
Detailed description
Up to now, 24 patients with major depression and 6 normal controls are enrolled. Twenty-three patients and 4 normal participants have taken 10 days rTMS. One patients and one control withdrew their consent without any reason and one control withdrew the consent because of headache.
We scanned fMRIs(to examine functional connectivity)twice for each participant, which were taken 3 days before the first and 3 days after the last rTMS.
All of participants have not reported side effects except mild headahe. There's been no seizure event up to now.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transcranial magnetic stimluation | Experimental | Device: repetitive transcranial magnetic stimulation(rTMS) |
| rTMS_sham | Sham comparator | Device: Sham repetitive transcranial magnetic stimulation(rTMS) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- DSM-IV major depressive episode
- Failure of at least 3 different kind of antidepressant
Key exclusion criteria (3 listed)
- Organic brain disorder
- Other diagnosis of DMS-IV except nicotine dependence
- History of seizure disorder
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 stimulation(rTMS)Also: MAGSTIM10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects. | Device | transcranial magnetic stimluation |
| Sham repetitive transcranial magnetic stimulation(rTMS)Sham repetitive transcranial magnetic stimulation(rTMS) | Device | rTMS_sham |
Primary outcome
change of functional connectivity between pre/post rTMS
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
- Derived from this study: PubMed 27379563Kang JI, Lee H, Jhung K, Kim KR, An SK, Yoon KJ, Kim SI, Namkoong K, Lee E. Frontostriatal Connectivity Changes in Major Depressive Disorder After Repetitive Transcranial Magnetic Stimulation: A Randomized Sham-Controlled Study. J Clin Psychiatry. 2016 Sep;77(9):e1137-e1143. doi: 10.4088/JCP.15m10110.
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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.
EUN LEE, M.D., Ph.D. principal investigator
Yonsei University College of Medicine, Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing repetitive transcranial magnetic stimulation(rTMS) in people with Major Depression, run by Yonsei University 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 3 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: finished, as of the sponsor's last update on 2 Feb 2012. 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. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of functional connectivity between pre/post rTMS (time frame: 14 days). 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 NCT01325831, 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 2 Feb 2012.