Accelerated LFR for Bipolar Patients During the COVID-19 Pandemic

NCT04427137 | Completed

• 1 other identifier: 071-2020
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in Hamilton Rating Scale for Depresion 24-it (HRSD-24)

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Response on Hamilton Rating Scale for Depresion 24-it (HRSD-24)

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Change in Young Mania Rating Scale (YMRS)

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Remission on Patient Health Questionnaire (PHQ-9)

  Up to 10 days (From screening/baseline to end of the acute treatment)

• Response on Patient Health Questionnaire (PHQ-9)

  Up to 10 days (From screening/baseline to end of the acute treatment)

Study Arms (1)

Accelerated LFR

EXPERIMENTAL

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.

Device: MagPro X100 Stimulator, B70 Fluid-Cooled Coil

Interventions

MagPro X100 Stimulator, B70 Fluid-Cooled Coil DEVICE

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.

Accelerated LFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

CAMH

Toronto, Ontario, M6H3J7, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Daniel Blumberger, MD

  CAMH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Head and Co-Director, Temerty Centre for Therapeutic Brain Intervention

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 11, 2020
• Study Start: June 9, 2020
• Primary Completion: January 9, 2022
• Study Completion: November 9, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CA (1)