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Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

Primary Purpose

Major Depressive Disorder

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MagPro X100 Stimulator, B70 Fluid-Cooled Coil
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, transcranial magnetic stimulation, treatment resistance, theta burst stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CAMH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Accelerated iTBS

Arm Description

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.

Outcomes

Primary Outcome Measures

Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Less than or equal to 10

Secondary Outcome Measures

Change in HRSD-24
changes in scores
Response on HRSD-24
50% Reduction in score
Remission on Patient Health Questionnaire (PHQ-9)
Less than or equal to 4
Response on PHQ-9
50% Reduction in score
Change in PHQ-9
changes in scores
Remission on General Anxiety Disorder 7 item (GAD-7)
Less than or equal to 4
Response on GAD-7
50% Reduction in score
Change in GAD-7
changes in scores
Remission on Beck Depression Inventory (BDI-II)
Less than or equal to 12
Response on BDI-II
50% Reduction in Score
Change on BDI-II
changes in scores
Remission on Beck Scale for Suicidal Ideation (SSI)
Score of 0
Change on SSI
changes in scores
Change in WHO Disability Assessment Schedule (WHODAS)
changes in scores
Proportion of Patients Maintaining Response During Relapse Prevention
Includes number of treatment days needed and number going on to receive ECT

Full Information

First Posted
May 8, 2020
Last Updated
July 22, 2022
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT04384965
Brief Title
Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
May 18, 2022 (Actual)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, transcranial magnetic stimulation, treatment resistance, theta burst stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accelerated iTBS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MagPro X100 Stimulator, B70 Fluid-Cooled Coil
Intervention Description
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 Measure Information:
Title
Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Description
Less than or equal to 10
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Outcome Measure Information:
Title
Change in HRSD-24
Description
changes in scores
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Response on HRSD-24
Description
50% Reduction in score
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Remission on Patient Health Questionnaire (PHQ-9)
Description
Less than or equal to 4
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Response on PHQ-9
Description
50% Reduction in score
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Change in PHQ-9
Description
changes in scores
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Remission on General Anxiety Disorder 7 item (GAD-7)
Description
Less than or equal to 4
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Response on GAD-7
Description
50% Reduction in score
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Change in GAD-7
Description
changes in scores
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Remission on Beck Depression Inventory (BDI-II)
Description
Less than or equal to 12
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Response on BDI-II
Description
50% Reduction in Score
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Change on BDI-II
Description
changes in scores
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Remission on Beck Scale for Suicidal Ideation (SSI)
Description
Score of 0
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Change on SSI
Description
changes in scores
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Change in WHO Disability Assessment Schedule (WHODAS)
Description
changes in scores
Time Frame
Up to 10 days (From screening/baseline to end of the acute treatment)
Title
Proportion of Patients Maintaining Response During Relapse Prevention
Description
Includes number of treatment days needed and number going on to receive ECT
Time Frame
24 weeks (Tapering and Relapse prevention phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Blumberger, MD
Organizational Affiliation
CAMH
Official's Role
Principal Investigator
Facility Information:
Facility Name
CAMH
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J1H4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

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