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Completed

NCT Number: NCT04935489

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

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robyn

Whitby, Ontario, M5P 3L9, Canada

About this study

Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

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

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

    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)

Secondary outcomes

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

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

    Change in severity of depressive symptoms (same as primary outcome description)

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

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

    Change in severity of anxiety symptoms - higher the score, more anxiety symptoms, range 0 to 21

  3. Change in World Health Organization Disability assessment scale (WHODAS)

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

    severity of disability ( 40 to 180 - higher score = more disabled)

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

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

    Change in rated quality of life, score range from 14 to 70 ( higher score = better quality of life)

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

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

    Change in severity of illness (1 - much worse, 7 - most improved)

  6. Patient Health Questionnaire (PHQ-9) - Response to symptoms

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

    reduction in depression score by 50% - higher the score - more depressive symptoms, scored from 0 to 27

Other outcomes

  1. Adverse effects of the treatment

    Time frame: during and after each rTMS treatment during acute treatment and up to a week after treatment

    Looking at occurrence of adverse effects - screened during/after each treatment

Sponsors and collaborators

Lead sponsor

Ontario Shores Centre for Mental Health Sciences

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2021
Registry last updated
Mar 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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