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Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04384965
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel Blumberger, Centre for Addiction and Mental Health

Brief Summary:
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : May 1, 2022
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Accelerated iTBS
In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.
Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~3 minutes) at a target of 110% of the subject's resting MT.




Primary Outcome Measures :
  1. Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    Less than or equal to 10


Secondary Outcome Measures :
  1. Change in HRSD-24 [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    changes in scores

  2. Response on HRSD-24 [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    50% Reduction in score

  3. Remission on Patient Health Questionnaire (PHQ-9) [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    Less than or equal to 4

  4. Response on PHQ-9 [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    50% Reduction in score

  5. Change in PHQ-9 [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    changes in scores

  6. Remission on General Anxiety Disorder 7 item (GAD-7) [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    Less than or equal to 4

  7. Response on GAD-7 [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    50% Reduction in score

  8. Change in GAD-7 [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    changes in scores

  9. Remission on Beck Depression Inventory (BDI-II) [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    Less than or equal to 12

  10. Response on BDI-II [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    50% Reduction in Score

  11. Change on BDI-II [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    changes in scores

  12. Remission on Beck Scale for Suicidal Ideation (SSI) [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    Score of 0

  13. Change on SSI [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    changes in scores

  14. Change in WHO Disability Assessment Schedule (WHODAS) [ Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment) ]
    changes in scores

  15. Proportion of Patients Maintaining Response During Relapse Prevention [ Time Frame: 24 weeks (Tapering and Relapse prevention phase) ]
    Includes number of treatment days needed and number going on to receive ECT



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Have unipolar depressive episode based on the MINI with or without psychotic symptoms
  • Have previous response to ECT or high symptom severity warranting acute ECT in the opinion of a consultant brain stimulation psychiatrist
  • Are over the age of 18
  • Pass the TMS adult safety screening (TASS) questionnaire
  • Are voluntary and competent to consent to treatment

Exclusion Criteria:

  • Have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month
  • Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, 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 take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
  • Lack of response to accelerated course of iTBS or rTMS in the past

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): NCT04384965


Contacts
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Contact: Nicole Schoer 416-535-8501 ext 30762 nicole.schoer@camh.ca
Contact: Mawahib Semeralul 416-535-8501 ext 30210 mawahib.semeralul@camh.ca

Locations
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Canada, Ontario
CAMH Recruiting
Toronto, Ontario, Canada, M6J1H4
Contact: Nicole Schoer    416-535-8501 ext 30762    nicole.schoer@camh.ca   
Principal Investigator: Daniel Blumberger, MD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Daniel Blumberger, MD CAMH
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Responsible Party: Daniel Blumberger, Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT04384965    
Other Study ID Numbers: 059/2020
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Blumberger, Centre for Addiction and Mental Health:
depression
transcranial magnetic stimulation
treatment resistance
theta burst stimulation
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders