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NCT04384965 | COMPLETED | Major Depressive Disorder

Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic
Sponsor:

Centre for Addiction and Mental Health

Information provided by (Responsible Party):

Daniel Blumberger

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.

Condition or disease

Major Depressive Disorder

Intervention/treatment

MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 176 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic
Actual Study Start Date : 2020-05-12
Estimated Primary Completion Date : 2022-05-18
Estimated Study Completion Date : 2022-11-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

Location Details

NCT04384965

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Ontario

Cuam

Toronto, Ontario, Canada, M6J1H4