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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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:

  1. are outpatients
  2. are voluntary and competent to consent to treatment
  3. 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
  4. are between the ages of 18 and 65
  5. 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)
  6. have a score ≥18 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
  7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  8. are able to adhere to the treatment schedule
  9. pass the TMS safety-screening questionnaire
  10. 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:

  1. have a history of substance dependence or abuse within the last 3 months
  2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  3. have active suicidal intent
  4. are pregnant
  5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
  6. 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
  7. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  8. have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
  9. 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
  10. 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
  11. 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
  12. have a clinically significant laboratory abnormality, in the opinion of the investigator
  13. 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
  14. 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
  • 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

    Recruiting

Other trials in Canada

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.

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 groups in NCT02778035
Study groupRoleWhat they receive
60 min inter-session intervalExperimentalRepetitive 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 intervalExperimentalRepetitive 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 intervalExperimentalRepetitive 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.

  1. 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)
  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.

  1. First posted19 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2019 (estimated)
  4. Study completionSep 2019 (estimated)

Resources

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)
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

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.

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