Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic
Not Applicable
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil
- Registration Number
- NCT04384965
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Accelerated iTBS MagPro X100 Stimulator, B70 Fluid-Cooled Coil 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.
- Primary Outcome Measures
Name Time Method Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) Up to 10 days (From screening/baseline to end of the acute treatment) Less than or equal to 10
- Secondary Outcome Measures
Name Time Method Response on HRSD-24 Up to 10 days (From screening/baseline to end of the acute treatment) 50% Reduction in score
Response on PHQ-9 Up to 10 days (From screening/baseline to end of the acute treatment) 50% Reduction in score
Remission on General Anxiety Disorder 7 item (GAD-7) Up to 10 days (From screening/baseline to end of the acute treatment) Less than or equal to 4
Remission on Beck Depression Inventory (BDI-II) Up to 10 days (From screening/baseline to end of the acute treatment) Less than or equal to 12
Response on BDI-II Up to 10 days (From screening/baseline to end of the acute treatment) 50% Reduction in Score
Change on BDI-II Up to 10 days (From screening/baseline to end of the acute treatment) changes in scores
Remission on Beck Scale for Suicidal Ideation (SSI) Up to 10 days (From screening/baseline to end of the acute treatment) Score of 0
Change on SSI Up to 10 days (From screening/baseline to end of the acute treatment) changes in scores
Proportion of Patients Maintaining Response During Relapse Prevention 24 weeks (Tapering and Relapse prevention phase) Includes number of treatment days needed and number going on to receive ECT
Change in HRSD-24 Up to 10 days (From screening/baseline to end of the acute treatment) changes in scores
Change in GAD-7 Up to 10 days (From screening/baseline to end of the acute treatment) changes in scores
Remission on Patient Health Questionnaire (PHQ-9) Up to 10 days (From screening/baseline to end of the acute treatment) Less than or equal to 4
Change in PHQ-9 Up to 10 days (From screening/baseline to end of the acute treatment) changes in scores
Response on GAD-7 Up to 10 days (From screening/baseline to end of the acute treatment) 50% Reduction in score
Change in WHO Disability Assessment Schedule (WHODAS) Up to 10 days (From screening/baseline to end of the acute treatment) changes in scores
Trial Locations
- Locations (1)
CAMH
🇨🇦Toronto, Ontario, Canada