DepressionNCT02702154
High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression
A study testing High-frequency rTMS and Low-frequency rTMS in people with Depression, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- High-frequency rTMS and Low-frequency rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Aug 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary and competent to consent to treatment
- MINI confirmed diagnosis of MDD
- Outpatient
- Between the ages of 18-65
- Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
- Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
- Must adhere to study assessment and intervention schedule.
- Pass the TMS Safety Screening Questionnaire.
Who cannot join
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical 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
- Have received rTMS for any previous indication due to the potential compromise of subject blinding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder
This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.
- Conditions
- Depression
- Being tested
- High-frequency rTMS, Low-frequency rTMS, Sham rTMS
- Keywords
- brain stimulation, rTMS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency rTMSDevice
Also called Magventure Cool DB80 Active/Placebo Coil
20 Hz active stimulation, twice daily
Low-frequency rTMSDevice
Also called Magventure Cool DB80 Active/Placebo Coil
1 Hz active stimulation, twice daily
Sham rTMSDevice
Also called Magventure Cool DB80 Active/Placebo Coil
Sham stimulation, twice daily
| Study group | Role | What they receive |
|---|---|---|
| High-frequency rTMS | Experimental | 20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks Receives: Device: High-frequency rTMS |
| Low-frequency rTMS | Experimental | 1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks Receives: Device: Low-frequency rTMS |
| Sham rTMS | Sham comparator | Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks Receives: Device: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D17 score
Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission.
Measured: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Secondary outcomes (2)
Beck Depression Inventory-II
Measured: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Beck anxiety inventory
Measured: Baseline, after each week (10 sessions) of treatment, and 2, 6, 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 posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018 (estimated)
- Study completionAug 2018 (estimated)
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 Health Network, TorontoThe 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, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Downar, University Health Network, Toronto
- Investigators
- Jonathan Downar, MD PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702154
- Sponsor's protocol ID
- 15-9276-A
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02702154
- Acronym / sponsor ID
- 15-9276-A
- Conditions
- Depression
- Keywords
- brain stimulation, rTMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 8 Mar 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 trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-frequency rTMS | Experimental | Device: High-frequency rTMS20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks |
| Low-frequency rTMS | Experimental | Device: Low-frequency rTMS1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks |
| Sham rTMS | Sham comparator | Device: Sham rTMSSham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 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)
- Voluntary and competent to consent to treatment
- MINI confirmed diagnosis of MDD
- Outpatient
- Between the ages of 18-65
- Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
Key exclusion criteria (5 listed)
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical 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
- Have received rTMS for any previous indication due to the potential compromise of subject blinding.
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 |
|---|---|---|
| High-frequency rTMSAlso: Magventure Cool DB80 Active/Placebo Coil20 Hz active stimulation, twice daily | Device | High-frequency rTMS |
| Low-frequency rTMSAlso: Magventure Cool DB80 Active/Placebo Coil1 Hz active stimulation, twice daily | Device | Low-frequency rTMS |
| Sham rTMSAlso: Magventure Cool DB80 Active/Placebo CoilSham stimulation, twice daily | Device | Sham rTMS |
Primary outcome
HAM-D17 score
Time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of <8 is categorized as remission.
2 secondary outcomes
Beck Depression Inventory-II
Time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Beck anxiety inventory
Time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- 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.
Jonathan Downar, MD PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency rTMS and Low-frequency rTMS in people with Depression, run by University Health Network, Toronto 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 5 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 30 Mar 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. 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?
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?
HAM-D17 score (time frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, 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?
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 30 Mar 2018.