Status:
COMPLETED
Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Bipolar Depression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose LFR protocol, including tapering treatments and symptom-based relapse prevention treatments,...
Detailed Description
Treatment resistant bipolar depression is a leading cause of disability and socioeconomic burden of disease, and current treatment options all suffer from critical deficiencies of efficacy, capacity, ...
Eligibility Criteria
Inclusion
- Currently are experiencing a bipolar depressive episode (bipolar disorder type 1 or 2) 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 one of the brain stimulation psychiatrists
- Are over the age of 18
- Pass the TMS adult safety screening (TASS) questionnaire
- Are voluntary and competent to consent to treatment
Exclusion
- have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of substance dependence or abuse within the last 1 month
- Currently experiencing a mixed or manic episode (YMRS \>12)
- have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of 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, 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 rTMS in the past
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04427137
Start Date
June 9 2020
End Date
November 9 2022
Last Update
February 20 2024
Active Locations (1)
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1
CAMH
Toronto, Ontario, Canada, M6H3J7