Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic

NCT04935489 | Completed

• 1 other identifier: 21-008-B
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (1)

• Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version

  Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)

  at screening (within a week of starting treatment) to a week post treatment

Secondary Outcomes (6)

• Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)

  at screening (within a week of starting treatment) to a week post treatment

• Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)

  at screening (within a week of starting treatment) to a week post treatment

• Change in World Health Organization Disability assessment scale (WHODAS)

  at screening (within a week of starting treatment) to a week post treatment

• Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)

  at screening (within a week of starting treatment) to a week post treatment

• Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)

  at screening (within a week of starting treatment) to a week post treatment

Other Outcomes (1)

• Adverse effects of the treatment

  during and after each rTMS treatment during acute treatment and up to a week after treatment

Study Arms (1)

Patients receiving accelerated rTMS

EXPERIMENTAL

Device: Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form

Interventions

Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form DEVICE

The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol

Patients receiving accelerated rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
• Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment

You may not qualify if:

• Have a MINI confirmed diagnosis of a substance use disorder within the last month
• Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
• Have a lifetime MINI diagnosis of bipolar I, or 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, or 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 taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.

Sponsors & Collaborators

• Ontario Shores Centre for Mental Health Sciences: lead

Study Sites (1)

Robyn

Whitby, Ontario, M5P 3L9, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Robyn Waxman

  Ontario Shores

  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: Head of Brain Stimulation Clinic

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 23, 2021
• Study Start: January 12, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

CA (1)