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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04384965
Other study ID # 059/2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 12, 2020
Est. completion date November 1, 2022

Study information

Verified date February 2024
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 176
Est. completion date November 1, 2022
Est. primary completion date May 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
Canada CAMH Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24) Less than or equal to 10 Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Change in HRSD-24 changes in scores Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Response on HRSD-24 50% Reduction in score Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Remission on Patient Health Questionnaire (PHQ-9) Less than or equal to 4 Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Response on PHQ-9 50% Reduction in score Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Change in PHQ-9 changes in scores Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Remission on General Anxiety Disorder 7 item (GAD-7) Less than or equal to 4 Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Response on GAD-7 50% Reduction in score Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Change in GAD-7 changes in scores Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Remission on Beck Depression Inventory (BDI-II) Less than or equal to 12 Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Response on BDI-II 50% Reduction in Score Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Change on BDI-II changes in scores Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Remission on Beck Scale for Suicidal Ideation (SSI) Score of 0 Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Change on SSI changes in scores Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Change in WHO Disability Assessment Schedule (WHODAS) changes in scores Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary Proportion of Patients Maintaining Response During Relapse Prevention Includes number of treatment days needed and number going on to receive ECT 24 weeks (Tapering and Relapse prevention phase)
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