Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427137
• Other study ID #: 071-2020
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: November 9, 2022

Study information

• Verified date: February 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 9, 2022
• Est. primary completion date: January 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• COVID-19
• Depression
• Depressive Disorder

Intervention

Device:
• MagPro X100 Stimulator, B70 Fluid-Cooled Coil
Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold.

Locations

Country	Name	City	State
Canada	CAMH	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)	Less than or equal to 10; This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)	changes in scores; This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)	50% Reduction in score; This scale is used to quantify the severity of symptoms of depression Scale range: 0-76 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in Young Mania Rating Scale (YMRS)	changes in scores; This scale is used to quantify the severity of symptoms of mania Scale range: 0-60 (total score) Lower scores indicate lower severity of manic symptoms (i.e., better outcome) Higher scores indicate higher severity of manic symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on Patient Health Questionnaire (PHQ-9)	Less than or equal to 4; This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on Patient Health Questionnaire (PHQ-9)	50% Reduction in score; This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in Patient Health Questionnaire (PHQ-9)	changes in scores; This scale is used to quantify the severity of symptoms of depression Scale range: 0-27 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on General Anxiety Disorder 7 item (GAD-7)	Less than or equal to 4; This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on General Anxiety Disorder 7 item (GAD-7)	50% Reduction in score; This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in General Anxiety Disorder 7 item (GAD-7)	changes in scores; This scale is used to quantify the severity of symptoms of anxiety Scale range: 0-21 (total score) Lower scores indicate lower severity of anxiety symptoms (i.e., better outcome) Higher scores indicate higher severity of anxiety symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on Beck Depression Inventory (BDI-II)	Less than or equal to 12; This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Response on Beck Depression Inventory (BDI-II)	50% Reduction in Score; This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change on Beck Depression Inventory (BDI-II)	changes in scores; This scale is used to quantify the severity of symptoms of depression Scale range: 0-63 (total score) Lower scores indicate lower severity of depressive symptoms (i.e., better outcome) Higher scores indicate higher severity of depressive symptoms (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Remission on Beck Scale for Suicidal Ideation (SSI)	Score of 0; This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change on Beck Scale for Suicidal Ideation (SSI)	changes in scores; This scale is used to assess the presence or absence of suicidal ideation and the degree of severity of suicidal ideas Scale range: 0 - 38 (total score) Lower scores indicate lower severity of suicidal ideation (i.e., better outcome) Higher scores indicate higher severity of suicidal ideation (i.e., worse outcome)	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38	changes in scores	Up to 10 days (From screening/baseline to end of the acute treatment)
Secondary	Proportion of Patients Maintaining Response During Relapse Prevention	Includes number of treatment days needed and number going on to receive ECT	24 weeks (Tapering and Relapse prevention phase)