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Completed

NCT Number: NCT04384965

Accelerated iTBS for Depressed Patients During the COVID-19 Pandemic

The current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aiTBS protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ECT and patients needing urgent treatment due to symptom severity during the COVID-19 pandemic.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAMH

Toronto, Ontario, M6J1H4, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have unipolar depressive episode 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 a consultant brain stimulation psychiatrist
  • 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
  • Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • Have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, 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 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 iTBS or rTMS in the past

Treatment and study plan

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 iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~3 minutes) at a target of 110% of the subject's resting MT.

Primary outcomes

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

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

    Less than or equal to 10

Secondary outcomes

  1. Change in HRSD-24

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

    changes in scores

  2. Response on HRSD-24

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

    50% Reduction in score

  3. Remission on Patient Health Questionnaire (PHQ-9)

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

    Less than or equal to 4

  4. Response on PHQ-9

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

    50% Reduction in score

  5. Change in PHQ-9

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

    changes in scores

  6. Remission on General Anxiety Disorder 7 item (GAD-7)

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

    Less than or equal to 4

  7. Response on GAD-7

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

    50% Reduction in score

  8. Change in GAD-7

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

    changes in scores

  9. Remission on Beck Depression Inventory (BDI-II)

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

    Less than or equal to 12

  10. Response on BDI-II

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

    50% Reduction in Score

  11. Change on BDI-II

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

    changes in scores

  12. Remission on Beck Scale for Suicidal Ideation (SSI)

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

    Score of 0

  13. Change on SSI

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

    changes in scores

  14. Change in WHO Disability Assessment Schedule (WHODAS)

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

    changes in scores

  15. Proportion of Patients Maintaining Response During Relapse Prevention

    Time frame: 24 weeks (Tapering and Relapse prevention phase)

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

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

A Novel and Practical Accelerated Intermittent Theta Burst Protocol as a Substitute for Depressed Patients Needing Electroconvulsive Therapy During the COVID-19 Pandemic

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 12, 2020
Registry last updated
Feb 20, 2024

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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