Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Centre for Addiction and Mental Health
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Updated on 16 February 2024
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depressed mood
depressive episode
psychosis
brain stimulation
depression
relapse prevention
psychotic symptoms
covid-19
major depressive disorder

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.

Details
Condition Major depression, Endogenous depression
Age 18years - 100years
Treatment MagPro X100 Stimulator, B70 Fluid-Cooled Coil
Clinical Study IdentifierNCT04384965
SponsorCentre for Addiction and Mental Health
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
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depressed mood
depressive episode
psychosis
brain stimulation
depression
relapse prevention
psychotic symptoms
covid-19
major depressive disorder

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