Depressive Disorder, MajorNCT02667041
NeuroQore rTMS (Monophasic vs. Biphasic) for Major Depressive Disorder: A Randomized Controlled Pilot Trial
A study testing NeuroQore rTMS Device in people with Depressive Disorder, Major, run by University of Ottawa at 1 site in Canada.
Trial summary
Major depressive disorder (MDD) is a debilitating illness that affects millions of individuals in North America and can result in clinical symptoms including loss of pleasure and feelings of worthlessness, in addition to significant cognitive impairments (e.g., memory, attention) that affect daily functioning. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- NeuroQore rTMS Device
- 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
- May 2015to Mar 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be included if they:
- are outpatients of the ROHCG
- are voluntary and competent to consent to treatment
- have a confirmed DSM-IV diagnosis of unipolar major depressive disorder
- are male or female
- are between the ages of 18 and 75
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- have failed to achieve a clinical response to an adequate dose of an antidepressant in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration
- have a score > 22 on the MADRS
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
- are able to adhere to the treatment schedule
- pass the TMS safety screening questionnaire (TASS)
- have normal thyroid functioning based on pre-study blood work
Who cannot join
- Patients will be excluded if they:
- have a history of substance dependence or abuse within the last 3 months or current substance use as indicated by a positive urine drug screen
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- are pregnant
- have a lifetime DSM-IV diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
Show all 16Show fewer
- have a DSM-IV 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, or personality disorder, assessed by a study investigator to be primary and causing greater impairment than MDD
- have failed a course of ECT in the current episode or previous episode
- have received rTMS for any previous indication due to the potential compromise of subject blinding
- have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
- clinically significant laboratory abnormality, in the opinion of the investigator
- currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview)
- failure of 3 or more adequate trials of medications of different drug classifications in the current episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NeuroQore Repetitive Transcranial Magnetic Monophasic vs. Biphasic Stimulation For Major Depressive Disorder: A Randomized Controlled Trial
Major depressive disorder (MDD) is a debilitating illness that affects millions of individuals in North America and can result in clinical symptoms including loss of pleasure and feelings of worthlessness, in addition to significant cognitive impairments (e.g., memory, attention) that affect daily functioning. Major depression bears a heavy burden for the individuals and family members afflicted, as well as an enormous health care and economic cost. Approximately half of major depressive patients seek out treatment for their illness and only 20% of those individuals report their treatment as satisfactory. Many MDD patients do not respond to pharmacological therapy following the first course of treatment, resulting in the need for alternative measures to alleviate the clinical and cognitive symptoms of treatment-resistant depression and the targeting of these therapies to better suit each individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted, non-invasive technique that utilizes currents to induce electrical fields that excite specific brain regions. The current recommended practice of rTMS involves the administration of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove more effective for the treatment of depression. The present study aims to determine the effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients through electrophysiological recordings of the brain taken before and after 6 weeks of stimulation. Additionally, the study aims to investigate various biological markers linked to clinical rTMS response; these brain markers will help in personalizing treatment for individuals suffering from MDD.
- Conditions
- Depressive Disorder, Major
- Being tested
- NeuroQore rTMS Device
- 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.
NeuroQore rTMS DeviceDevice
| Study group | Role | What they receive |
|---|---|---|
| rTMS treatment (Monophasic vs. biphasic) | Experimental | Safety and efficacy Receives: Device: NeuroQore rTMS Device |
| EEG/ERP biomarkers | Active comparator | Investigation of pre- and post-treatment cognitive biomarkers Receives: Device: NeuroQore rTMS Device |
| Blood biomarkers | Active comparator | Investigation of pre- and post-treatment protein biomarkers Receives: Device: NeuroQore rTMS Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS) scores
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startMay 2015
- Primary completionMar 2018
- Study completionMar 2018
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 Disorder, MajorStudies 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, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroQore Inc.
- Responsible party
- Principal investigator, Dr. Verner Knott, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667041
- Sponsor's protocol ID
- 2015014
- Status last verified
- Nov 2018
- First submitted
- 25 Jan 2016
- Last updated
- 16 Nov 2018
- Results posted
- No
Publications
Goodman MS, Blumberger DM, Talebinejad M, Chan ADC, Chen R, Yang TT. Rectangular Repetitive Transcranial Magnetic Monophasic vs Biphasic Stimulation for Major Depressive Disorder: A Randomized Controlled Pilot Trial. Neuromodulation. 2025 Apr;28(3):511-519. doi: 10.1016/j.neurom.2024.11.010. Epub 2025 Jan 6.
PubMed 39772341
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroQore Repetitive Transcranial Magnetic Monophasic vs. Biphasic Stimulation For Major Depressive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02667041
- Acronym / sponsor ID
- 2015014
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- NeuroQore Inc.
- Study start
- May 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 28 Jan 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.
Major depressive disorder (MDD) is a debilitating illness that affects millions of individuals in North America and can result in clinical symptoms including loss of pleasure and feelings of worthlessness, in addition to significant cognitive impairments (e.g., memory, attention) that affect daily functioning. Major depression bears a heavy burden for the individuals and family members afflicted, as well as an enormous health care and economic cost. Approximately half of major depressive patients seek out treatment for their illness and only 20% of those individuals report their treatment as satisfactory. Many MDD patients do not respond to pharmacological therapy following the first course of treatment, resulting in the need for alternative measures to alleviate the clinical and cognitive symptoms of treatment-resistant depression and the targeting of these therapies to better suit each individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted, non-invasive technique that utilizes currents to induce electrical fields that excite specific brain regions. The current recommended practice of rTMS involves the administration of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove more effective for the treatment of depression. The present study aims to determine the effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients through electrophysiological recordings of the brain taken before and after 6 weeks of stimulation. Additionally, the study aims to investigate various biological markers linked to clinical rTMS response; these brain markers will help in personalizing treatment for individuals suffering from MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rTMS treatment (Monophasic vs. biphasic) | Experimental | Device: NeuroQore rTMS DeviceSafety and efficacy |
| EEG/ERP biomarkers | Active comparator | Device: NeuroQore rTMS DeviceInvestigation of pre- and post-treatment cognitive biomarkers |
| Blood biomarkers | Active comparator | Device: NeuroQore rTMS DeviceInvestigation of pre- and post-treatment protein biomarkers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- are outpatients of the ROHCG
- are voluntary and competent to consent to treatment
- have a confirmed DSM-IV diagnosis of unipolar major depressive disorder
- are male or female
- are between the ages of 18 and 75
Key exclusion criteria (16 listed)
- have a history of substance dependence or abuse within the last 3 months or current substance use as indicated by a positive urine drug screen
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- are pregnant
- have a lifetime DSM-IV diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, 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 |
|---|---|---|
| NeuroQore rTMS Device | Device | Blood biomarkers, EEG/ERP biomarkers, rTMS treatment (Monophasic vs. biphasic) |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) scores
Time frame: Six weeks
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 16 Nov 2018.
- Derived from this study: PubMed 39772341Goodman MS, Blumberger DM, Talebinejad M, Chan ADC, Chen R, Yang TT. Rectangular Repetitive Transcranial Magnetic Monophasic vs Biphasic Stimulation for Major Depressive Disorder: A Randomized Controlled Pilot Trial. Neuromodulation. 2025 Apr;28(3):511-519. doi: 10.1016/j.neurom.2024.11.010. Epub 2025 Jan 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroQore rTMS Device in people with Depressive Disorder, Major, run by University of Ottawa 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 12 inclusion and 16 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 16 Nov 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.
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?
Montgomery-Åsberg Depression Rating Scale (MADRS) scores (time frame: Six weeks). 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 NCT02667041, 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 16 Nov 2018.