A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic

Centre for Addiction and Mental Health1 site in 1 country176 target enrollmentMay 12, 2020

ConditionsMajor Depressive Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Major Depressive Disorder
Sponsor: Centre for Addiction and Mental Health
Enrollment: 176
Locations: 1
Primary Endpoint: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 12, 2020

End Date

November 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre for Addiction and Mental Health

Responsible Party

Principal Investigator

Daniel Blumberger

Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention

Centre for Addiction and Mental Health

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

Outcomes

Primary Outcomes

Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Time Frame: Up to 10 days (From screening/baseline to end of the acute treatment)

Less than or equal to 10

Secondary Outcomes

Remission on Beck Depression Inventory (BDI-II)(Up to 10 days (From screening/baseline to end of the acute treatment))
Response on HRSD-24(Up to 10 days (From screening/baseline to end of the acute treatment))
Response on PHQ-9(Up to 10 days (From screening/baseline to end of the acute treatment))
Remission on General Anxiety Disorder 7 item (GAD-7)(Up to 10 days (From screening/baseline to end of the acute treatment))
Response on BDI-II(Up to 10 days (From screening/baseline to end of the acute treatment))
Change on BDI-II(Up to 10 days (From screening/baseline to end of the acute treatment))
Remission on Beck Scale for Suicidal Ideation (SSI)(Up to 10 days (From screening/baseline to end of the acute treatment))
Change on SSI(Up to 10 days (From screening/baseline to end of the acute treatment))
Proportion of Patients Maintaining Response During Relapse Prevention(24 weeks (Tapering and Relapse prevention phase))
Change in HRSD-24(Up to 10 days (From screening/baseline to end of the acute treatment))
Change in GAD-7(Up to 10 days (From screening/baseline to end of the acute treatment))
Remission on Patient Health Questionnaire (PHQ-9)(Up to 10 days (From screening/baseline to end of the acute treatment))
Change in PHQ-9(Up to 10 days (From screening/baseline to end of the acute treatment))
Response on GAD-7(Up to 10 days (From screening/baseline to end of the acute treatment))
Change in WHO Disability Assessment Schedule (WHODAS)(Up to 10 days (From screening/baseline to end of the acute treatment))