Depression; Bipolar DisorderNCT02778035
Comparing Different Patterns of rTMS in Major Depression
A study testing Dorsomedial prefrontal rTMS in people with Depression; Bipolar Disorder, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
This trial will compare the trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression; Bipolar Disorder
- What is being tested?
- Dorsomedial prefrontal rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2016to Sep 2019
- 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
Participants are eligible for the study if they:
- are outpatients
- are voluntary and competent to consent to treatment
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of major depressive disorder (MDD), single or recurrent, or Bipolar Disorder with a current Major Depressive Episode
- are between the ages of 18 and 65
- have 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 ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- 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
- have normal thyroid functioning and no clinically significant abnormalities on complete blood count (CBC), on pre-study blood work.
Participants are ineligible for the study if they:
- 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-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, 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 a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
- 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
- have a clinically significant laboratory abnormality, in the opinion of the investigator
- currently (or in the last 4 weeks prior to the study) have taken more than lorazepam 4 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
UHN MRI-Guided rTMS Clinic, Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Laura Schulze, 416-603-5667, laura.schulze@uhn.ca
Terri Cairo, 416-603-5667, terri.cairo@uhn.ca
- Recruiting
Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Shobha Mehta, shobha.mehta@camh.ca
Daniel M Blumberger, MD MSc
About this study
Official title: A Randomized Controlled Trial Comparing Different Patterns of Repetitive Transcranial Magnetic Stimulation in the Treatment of Refractory Depression
This trial will compare the trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals.
- Conditions
- Depression; Bipolar Disorder
- Being tested
- Dorsomedial prefrontal rTMS
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dorsomedial prefrontal rTMSDevice
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
| Study group | Role | What they receive |
|---|---|---|
| 60 min inter-session interval | Experimental | Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min). Receives: Device: Dorsomedial prefrontal rTMS |
| 30 min inter-session interval | Experimental | Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min). Receives: Device: Dorsomedial prefrontal rTMS |
| 0 min inter-session interval | Experimental | Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min). Receives: Device: Dorsomedial prefrontal rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
17-Item Hamilton Rating Scale for Depression (HAMD-17)
Outcome measured by a change in HAMD-17 score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤7 is categorized as remission.
Measured: Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).
Secondary outcomes (1)
Beck Depression Inventory-II (BDI-II)
Outcome measured by a change in BDI-II score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤12 is categorized as remission.
Measured: Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 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 posted19 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
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 Depression; Bipolar DisorderStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778035
- Sponsor's protocol ID
- 15-9615
- Status last verified
- Feb 2018
- First submitted
- 12 May 2016
- Last updated
- 14 Mar 2018
- Results posted
- No
Publications
Goodman MS, Schulze L, Daskalakis ZJ, Konstantinou GN, Mansouri F, Trevizol AP, Blumberger DM, Downar J. Randomised controlled trial comparing different intersession intervals of intermittent theta burst delivered to the dorsal medial prefrontal cortex. BMJ Ment Health. 2024 Oct 23;27(1):e301290. doi: 10.1136/bmjment-2024-301290.
PubMed 39448077
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Different Patterns of Repetitive Transcranial Magnetic Stimulation in the Treatment of Refractory Depression
- ClinicalTrials.gov ID
- NCT02778035
- Acronym / sponsor ID
- 15-9615
- Conditions
- Depression; Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Centre for Addiction and Mental Health
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 May 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 trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 60 min inter-session interval | Experimental | Device: Dorsomedial prefrontal rTMSRepetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min). |
| 30 min inter-session interval | Experimental | Device: Dorsomedial prefrontal rTMSRepetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min). |
| 0 min inter-session interval | Experimental | Device: Dorsomedial prefrontal rTMSRepetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Dorsomedial prefrontal rTMSDorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval | Device | 0 min inter-session interval, 30 min inter-session interval, 60 min inter-session interval |
Primary outcome
17-Item Hamilton Rating Scale for Depression (HAMD-17)
Time frame: Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).
Outcome measured by a change in HAMD-17 score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤7 is categorized as remission.
1 secondary outcome
Beck Depression Inventory-II (BDI-II)
Time frame: Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, 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 14 Mar 2018.
- Derived from this study: PubMed 39448077Goodman MS, Schulze L, Daskalakis ZJ, Konstantinou GN, Mansouri F, Trevizol AP, Blumberger DM, Downar J. Randomised controlled trial comparing different intersession intervals of intermittent theta burst delivered to the dorsal medial prefrontal cortex. BMJ Ment Health. 2024 Oct 23;27(1):e301290. doi: 10.1136/bmjment-2024-301290.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorsomedial prefrontal rTMS in people with Depression; Bipolar Disorder, run by University Health Network, Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 14 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Schulze (416-603-5667 ext. 6513, laura.schulze@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
17-Item Hamilton Rating Scale for Depression (HAMD-17) (time frame: Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).). 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 NCT02778035, 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 14 Mar 2018.