Major Depressive DisorderPhase 3NCT02800226
Pilot Study Comparing 10hz vs Theta Burst Stimulation
A Phase 3 study testing 10Hz and iTBS in people with Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
Trial summary
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- 10Hz and iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- outpatients
- voluntary and competent to consent
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
- failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
- have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule
- Pass the TMS adult safety screening (TASS) questionnaire
- have normal thyroid functioning based on pre-study blood work
Who cannot join
- have a history of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- are pregnant
- have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
- have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
Trial locations and contacts
1 site in 1 country.
Canada1 site
Non-Invasive Neurostimulation Therapies lab, University of British Columbia
Vancouver, British Columbia, V6T2A1
About this study
Official title: Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response
- Conditions
- Major Depressive Disorder
- Being tested
- 10Hz, iTBS
- 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.
10HzDevice
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
iTBSDevice
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
| Study group | Role | What they receive |
|---|---|---|
| 10Hz | Experimental | High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks Receives: Device: 10Hz |
| iTBS | Active comparator | intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks Receives: Device: iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.
Measured: baseline, 1, 4, and 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fidel Vila-Rodriguez, University of British Columbia
- Investigators
- Fidel Vila-Rodriguez, MD, Principal investigator, University of British Columia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800226
- Sponsor's protocol ID
- H13-02340
- Status last verified
- Aug 2018
- First submitted
- 10 Jun 2016
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tadayon P, MacKenzie A, Gregory E, Pichardo S, Gorges M, Vila-Rodriguez F. Quantification of Transcranial Magnetic Stimulation and Low-intensity Focused Ultrasound Energy Field Focality in the Cerebral Cortex. Neuromodulation. 2026 Feb 27:S1094-7159(26)00027-9. doi: 10.1016/j.neurom.2026.01.014. Online ahead of print.
PubMed 41758099Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.
PubMed 31668646Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.
PubMed 30425640
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression
- ClinicalTrials.gov ID
- NCT02800226
- Acronym / sponsor ID
- H13-02340
- Conditions
- Major Depressive Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jun 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.
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 10Hz | Experimental | Device: 10HzHigh Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks |
| iTBS | Active comparator | Device: iTBSintermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- outpatients
- voluntary and competent to consent
- Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
- failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
- have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
Key exclusion criteria (6 listed)
- have a history of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- are pregnant
- have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
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 |
|---|---|---|
| 10HzMagventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System | Device | 10Hz |
| iTBSMagventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System | Device | iTBS |
Primary outcome
Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score
Time frame: baseline, 1, 4, and 12 weeks post-treatment
A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.
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 10 Aug 2018.
- Derived from this study: PubMed 41758099Tadayon P, MacKenzie A, Gregory E, Pichardo S, Gorges M, Vila-Rodriguez F. Quantification of Transcranial Magnetic Stimulation and Low-intensity Focused Ultrasound Energy Field Focality in the Cerebral Cortex. Neuromodulation. 2026 Feb 27:S1094-7159(26)00027-9. doi: 10.1016/j.neurom.2026.01.014. Online ahead of print.
- Derived from this study: PubMed 31668646Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.
- Derived from this study: PubMed 30425640Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.
- Laboratory WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Fidel Vila-Rodriguez, MD principal investigator
University of British Columia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10Hz and iTBS in people with Major Depressive Disorder, run by University of British Columbia at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 10 Aug 2018. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 in the Hamilton Depression Rating scale 17-item (HDRS-17) score (time frame: baseline, 1, 4, and 12 weeks post-treatment). 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 NCT02800226, which also lists 3 linked publications.
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 10 Aug 2018.