Clinical trial NCT04427137: Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic
Official title: A Novel and Practical Accelerated Low-frequency Right-sided Stimulation Protocol as a Substitute for Patients With Bipolar Depression Needing Electroconvulsive Therapy During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Keywords: bipolar depression
transcranial magnetic stimulation
treatment resistance
low-frequency right-side stimulation
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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, in patients with bipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

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, or tolerability, especially given the current COVID-19 pandemic. rTMS and aLFR in particular has the potential to overcome many of these deficiencies, and is safe and well-tolerated. Taken together with the reported findings of other groups, aLFR may be feasible, tolerable, and capable of achieving comparable and potentially better remission rates than longer 20 to 30-day courses and it may also be beneficial to taper treatments and use symptom-based relapse prevention treatments in an aLFR protocol. Importantly, our pilot data in two patients previously responsive to ECT and data from the Cole et al. study suggest that accelerated rTMS may be a potential substitute for ECT as it may be possible to achieve remission in patients with severe depressive symptoms who would otherwise receive ECT. Furthermore, there is a burden of being able to provide care to as many people as possible based on severity of illness during the pandemic.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary outcomes:
measure: Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in Young Mania Rating Scale (YMRS)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on General Anxiety Disorder 7 item (GAD-7)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on General Anxiety Disorder 7 item (GAD-7)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in General Anxiety Disorder 7 item (GAD-7)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on Beck Depression Inventory (BDI-II)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Response on Beck Depression Inventory (BDI-II)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change on Beck Depression Inventory (BDI-II)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Remission on Beck Scale for Suicidal Ideation (SSI)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change on Beck Scale for Suicidal Ideation (SSI)
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38
timeFrame: Up to 10 days (From screening/baseline to end of the acute treatment)
measure: Proportion of Patients Maintaining Response During Relapse Prevention
timeFrame: 24 weeks (Tapering and Relapse prevention phase)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: CAMH
state: Ontario
Study officials:
affiliation: CAMH
name: Daniel Blumberger, MD
role: PRINCIPAL_INVESTIGATOR
References: