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Completed

NCT Number: NCT02998580

Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the bilateral theta burst protocol has similar effectiveness to the conventional bilateral rTMS protocol in treating major depression.

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Key information

Age range

60 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

  • are an outpatient
  • are ≥60 years old
  • have a Mini-International Neuropsychiatric Interview (MINI 6.0)67 confirmed diagnosis of MDD, with a current MDE
  • have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode or have failed to tolerate two separate trials of an antidepressant
  • have a score > 17 on the MADRS
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  • have normal electrolytes, hemoglobin and thyroid functioning based on pre-study blood work
  • Pass the TMS adult safety screening (TASS) questionnaire
  • Are able to have an MRI

Exclusion criteria

  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness determined by one of the study physicians
  • have active suicidal intent
  • have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
  • have current psychotic symptoms
  • have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, assessed by a study investigator to be primary. One of these comorbidities will not be exclusionary if they are not deemed to be primary.
  • have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  • have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10.
  • did not respond to a course of ECT in the current depressive episode
  • have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible
  • have a history of a primary seizure disorder or a seizure associated with an intracranial lesion.
  • 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
  • have a implanted electronic device that is currently function such as a defibrillator
  • currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
  • if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
  • non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Treatment and study plan

LFR followed by HFL

Device

Magventure Cool B70 Coil with RX100 Stimulator

cTBS followed by iTBS

Device

Magventure Cool B70 Coil with RX100 Stimulator

Primary outcomes

  1. Change on the Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: After 4 or 6 weeks

    Change from baseline to week 4 or 6 endpoint

Secondary outcomes

  1. Remission on the MADRS

    Time frame: After 4 or 6 weeks

    Score less than or equal to 10

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • University Health Network, Toronto

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 20, 2016
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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