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Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic

Primary Purpose

Bipolar Depression

Status

Active

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

MagPro X100 Stimulator, B70 Fluid-Cooled Coil

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring bipolar depression, transcranial magnetic stimulation, treatment resistance, low-frequency right-side stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CAMH

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Accelerated LFR

Arm Description

In the acute treatment phase, treatment will occur 8 times daily (50 min pause between treatments) on weekdays, until symptom remission is achieved (HRSD-24 score < to 10) or a maximum of 10 working days of daily treatment. In the tapering phase, treatments will be reduced to 2 treatment days per week for 2 weeks and then 1 treatment day per week for 2 weeks (4 weeks total). Patients that have responded to treatment will then enter the symptom-based relapse prevention phase including virtual check-in with study staff and a treatment schedule based on symptom level according to a modified relapse prevention algorithm that has been developed to prevent relapse after a successful course of ECT (known as the STABLE algorithm). The relapse prevention phase will last a maximum of 6 months.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Change in WHO Disability Assessment Schedule (WHODAS) Range 0-38

changes in scores

Proportion of Patients Maintaining Response During Relapse Prevention

Includes number of treatment days needed and number going on to receive ECT

Full Information

NCT ID

NCT04427137

First Posted

June 10, 2020

Last Updated

July 22, 2022

Sponsor

Centre for Addiction and Mental Health

1. Study Identification

Unique Protocol Identification Number

NCT04427137

Brief Title

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

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 9, 2020 (Actual)

Primary Completion Date

January 9, 2022 (Actual)

Study Completion Date

November 9, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression

Keywords

bipolar depression, transcranial magnetic stimulation, treatment resistance, low-frequency right-side stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Accelerated LFR

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion achieving remission on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

Description

Time Frame