- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04255784
High Dose Accelerated iTBS for Depression
February 16, 2024 updated by: Daniel Blumberger, Centre for Addiction and Mental Health
A Randomized Sham-Controlled Trial of High-Dosage Accelerated Intermittent Theta Burst rTMS in Major Depression
This trial will compare active intermittent theta burst stimulation (iTBS) rTMS in an accelerated treatment schedule (8 treatment sessions per day for 5 days) to a placebo control.
Depression symptom severity will be measured before, during, at end of treatment, 1-week post and 4-weeks post treatment.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Those participants who do not meet the response criterion (50% improvement from baseline on the HRDS-17) at the 4-week follow-up will be offered a second course of treatment, regardless of whether they were in the active or the sham treatment group.
The blind will be maintained and no further assessment contributing to the primary or secondary outcomes will occur after the 4-week time point.
A different operator will administer the open-label second course of treatment to ensure blinding of operators.
The second course of treatment will apply active rTMS using low-frequency (1 Hz) stimulation to the right DLPFC for 600 pulses (10 minutes), 8x daily at 50 minutes (between session and end and start) intervals for 5 days.
All those completing the second course of treatment will undergo the same set of clinical assessments during and after the course of treatment on the same schedule as the first course of treatment.
The final 4-week follow up assessment from the first course of treatment will serve as the baseline for those that go on to receive the second open label treatment course.
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elizabeth Clancy
- Phone Number: 36434 416-535-8501
- Email: Elizabeth.Clancy@camh.ca
Study Contact Backup
- Name: Mawahib Semeralul
- Phone Number: 30210 416-535-8501
- Email: mawahib.semeralul@camh.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T2A1
- Not yet recruiting
- University of British Columbia
-
Contact:
- Afifa Humaira
- Phone Number: 604-822-7308
- Email: afifa.humaira@ubc.ca
-
Principal Investigator:
- Fidel Vila-Rodriguez, MD
-
-
Ontario
-
Toronto, Ontario, Canada, M6J1H4
- Recruiting
- CAMH
-
Contact:
- Elizabeth Clancy
- Phone Number: 36434 416-535-8501
- Email: Elizabeth.Clancy@camh.ca
-
Principal Investigator:
- Daniel M. Blumberger, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- are outpatients
- are voluntary and competent to consent to treatment
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single or recurrent
- are between the ages of 18 and 65
- have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score for that antidepressant trial 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 score of 1 or 2 on those 2 separate antidepressants)
- have a score > 18 on the HRSD-17 item
- have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
- able to adhere to the treatment schedule
- Pass the TMS adult safety screening (TASS) questionnaire
- have normal thyroid functioning based on pre-study blood work.
Exclusion Criteria:
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 3 months
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have active suicidal intent
- are pregnant
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- 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, that is assessed by a study investigator to be primary and causing greater impairment than MDD
- have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
- have failed a course of ECT in the current episode or previous episode
- have received rTMS for any previous indication due to the potential compromise of subject blinding
- 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, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, 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
- 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
- clinically significant laboratory abnormality, in the opinion of the one of the principal investigators or study physicians
- currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
- non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active iTBS
Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days.
Each session will deliver 1800 pulses of active 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 / ~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
|
Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
|
Sham Comparator: Sham iTBS
Administered 8 times daily at approximately 50 minutes intervals (between session end and start) for 5 days, using a sham coil that reproduces auditory and tactile sensations of stimulation and has an identical external appearance.
Each session will deliver 1800 pulses of sham 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 / ~10 minutes) at a target intensity of 110% of the subject's resting motor threshold.
|
Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Time Frame: After 5 treatment days
|
ITT
|
After 5 treatment days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
Time Frame: one week and four weeks post treatment
|
ITT
|
one week and four weeks post treatment
|
Proportion of participants achieving response (50% reduction in HRSD-17) and remission (HRSD-17 <8)
Time Frame: After 5 treatment days and at 1-week and 4 weeks post-treatment
|
ITT
|
After 5 treatment days and at 1-week and 4 weeks post-treatment
|
Change on the Beck Depression Inventory-II (BDI-II)
Time Frame: After 5 treatment days and at 1-week and 4 weeks post-treatment
|
ITT
|
After 5 treatment days and at 1-week and 4 weeks post-treatment
|
Change on the Generalized Anxiety Disorder 7-Item (GAD-7)
Time Frame: After 5 treatment days and at 1-week and 4 weeks post-treatment
|
ITT
|
After 5 treatment days and at 1-week and 4 weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Blumberger, MD, CAMH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 6, 2020
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
February 1, 2025
Study Registration Dates
First Submitted
February 3, 2020
First Submitted That Met QC Criteria
February 3, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 109-2019
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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