Treatment Resistant DepressionNCT04935489
Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
A study testing Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form in people with Treatment Resistant Depression, run by Ontario Shores Centre for Mental Health Sciences at 1 site in Canada.
Trial summary
Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jan 2022to 15 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
- Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment
Who cannot join
- Have a MINI confirmed diagnosis of a substance use disorder within the last month
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
- Have a lifetime MINI diagnosis of bipolar I, or schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder.
- 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, or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 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.
- Currently taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.
Trial locations and contacts
1 site in 1 country.
About this study
Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.
Read the detailed description
Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .
- Conditions
- Treatment Resistant Depression
- Being tested
- Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated formDevice
The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving accelerated rTMS | Experimental | Not described Receives: Device: Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
Measured: at screening (within a week of starting treatment) to a week post treatment
Secondary outcomes (6)
Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)
Change in severity of depressive symptoms (same as primary outcome description)
Measured: at screening (within a week of starting treatment) to a week post treatment
Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)
Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21
Measured: at screening (within a week of starting treatment) to a week post treatment
Change in World Health Organization Disability assessment scale (WHODAS)
severity of disability ( 40 to 180 - higher score = more disabled)
Measured: at screening (within a week of starting treatment) to a week post treatment
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)
Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)
Measured: at screening (within a week of starting treatment) to a week post treatment
Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)
Change in severity of illness (1 - much worse, 7 - most improved)
Measured: at screening (within a week of starting treatment) to a week post treatment
Patient Health Questionnaire (PHQ-9) - Response to symptoms
reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27
Measured: at screening (within a week of starting treatment ) to a week post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start12 Jan 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Shores Centre for Mental Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Robyn Waxman, Ontario Shores Centre for Mental Health Sciences
- Investigators
- Robyn Waxman, Principal investigator, Ontario Shores
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935489
- Sponsor's protocol ID
- 21-008-B
- Status last verified
- Mar 2023
- First submitted
- 11 Jun 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04935489
- Acronym / sponsor ID
- 21-008-B
- Conditions
- Treatment Resistant Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ontario Shores Centre for Mental Health SciencesUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 23 Jun 2021 (actual)
- 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.
Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.
Detailed description
Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving accelerated rTMS | Experimental | Device: Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
- Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment
Key exclusion criteria (6 listed)
- Have a MINI confirmed diagnosis of a substance use disorder within the last month
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
- Have a lifetime MINI diagnosis of bipolar I, or schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder.
- 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, or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 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.
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 |
|---|---|---|
| Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated formThe intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol | Device | Patients receiving accelerated rTMS |
Primary outcome
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
Time frame: at screening (within a week of starting treatment) to a week post treatment
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
6 secondary outcomes
Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Change in World Health Organization Disability assessment scale (WHODAS)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)
Time frame: at screening (within a week of starting treatment) to a week post treatment
Patient Health Questionnaire (PHQ-9) - Response to symptoms
Time frame: at screening (within a week of starting treatment ) to a week post treatment
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 23 Mar 2023.
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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.
Robyn Waxman principal investigator
Ontario Shores
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form in people with Treatment Resistant Depression, run by Ontario Shores Centre for Mental Health Sciences 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 3 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 23 Mar 2023. 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?
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version (time frame: at screening (within a week of starting treatment) to a week 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 23 Mar 2023.