Back to resultsAccelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
Primary Purpose
Treatment Resistant Depression
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
Inclusion Criteria:
- 18 years and older
- Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
- Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment
Exclusion Criteria:
- Have a MINI confirmed diagnosis of a substance use disorder within the last month
- Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
- Have a lifetime MINI diagnosis of bipolar I, or 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 taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.
Sites / Locations
- Robyn
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients receiving accelerated rTMS
Arm Description
Outcomes
Primary Outcome Measures
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
Secondary Outcome Measures
Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)
Change in severity of depressive symptoms (same as primary outcome description)
Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)
Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21
Change in World Health Organization Disability assessment scale (WHODAS)
severity of disability ( 40 to 180 - higher score = more disabled)
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)
Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)
Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)
Change in severity of illness (1 - much worse, 7 - most improved)
Patient Health Questionnaire (PHQ-9) - Response to symptoms
reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27
Full Information
NCT ID
NCT04935489
First Posted
June 11, 2021
Last Updated
March 22, 2023
Sponsor
Ontario Shores Centre for Mental Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04935489
Brief Title
Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
Official Title
Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ontario Shores Centre for Mental Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.
Detailed Description
Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients receiving accelerated rTMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form
Intervention Description
The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol
Primary Outcome Measure Information:
Title
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
Description
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
Time Frame
at screening (within a week of starting treatment) to a week post treatment
Secondary Outcome Measure Information:
Title
Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)
Description
Change in severity of depressive symptoms (same as primary outcome description)
Time Frame
at screening (within a week of starting treatment) to a week post treatment
Title
Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)
Description
Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21
Time Frame
at screening (within a week of starting treatment) to a week post treatment
Title
Change in World Health Organization Disability assessment scale (WHODAS)
Description
severity of disability ( 40 to 180 - higher score = more disabled)
Time Frame
at screening (within a week of starting treatment) to a week post treatment
Title
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)
Description
Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)
Time Frame
at screening (within a week of starting treatment) to a week post treatment
Title
Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)
Description
Change in severity of illness (1 - much worse, 7 - most improved)
Time Frame
at screening (within a week of starting treatment) to a week post treatment
Title
Patient Health Questionnaire (PHQ-9) - Response to symptoms
Description
reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27
Time Frame
at screening (within a week of starting treatment ) to a week post treatment
Other Pre-specified Outcome Measures:
Title
Adverse effects of the treatment
Description
Looking at occurrence of adverse effects - screened during/after each treatment
Time Frame
during and after each rTMS treatment during acute treatment and up to a week after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years and older
Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment
Exclusion Criteria:
Have a MINI confirmed diagnosis of a substance use disorder within the last month
Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
Have a lifetime MINI diagnosis of bipolar I, or 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 taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Waxman
Organizational Affiliation
Ontario Shores
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robyn
City
Whitby
State/Province
Ontario
ZIP/Postal Code
M5P 3L9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
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