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Comparing Different Patterns of rTMS in Major Depression

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ClinicalTrials.gov Identifier: NCT02778035
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Depression; Bipolar Disorder Device: Dorsomedial prefrontal rTMS Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Different Patterns of Repetitive Transcranial Magnetic Stimulation in the Treatment of Refractory Depression
Actual Study Start Date : April 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 60 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min).
Device: Dorsomedial prefrontal rTMS
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval

Experimental: 30 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min).
Device: Dorsomedial prefrontal rTMS
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval

Experimental: 0 min inter-session interval
Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min).
Device: Dorsomedial prefrontal rTMS
Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778035


Contacts
Contact: Laura Schulze 416-603-5667 ext 6513 laura.schulze@uhn.ca
Contact: Terri Cairo 416-603-5667 ext 4950 terri.cairo@uhn.ca

Locations
Canada, Ontario
UHN MRI-Guided rTMS Clinic, Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Laura Schulze    416-603-5667    laura.schulze@uhn.ca   
Contact: Terri Cairo    416-603-5667    terri.cairo@uhn.ca   
Principal Investigator: Jonathan Downar, MD PhD FRCPC         
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Contact: Shobha Mehta       shobha.mehta@camh.ca   
Principal Investigator: Daniel M Blumberger, MD MSc         
Sub-Investigator: Zafiris J Daskalakis, MD PhD         
Sponsors and Collaborators
University Health Network, Toronto
Centre for Addiction and Mental Health

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02778035     History of Changes
Other Study ID Numbers: 15-9615
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders