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OpenTrials
Completed

NCT Number: NCT01887782

Randomized Controlled Trial of Conventional vs Theta Burst rTMS

This trial will compare a novel form of rTMS, intermittent Theta Burst Stimulation to the standard conventional high frequency left sided stimulation protocol. The Left dorsolateral prefrontal cortex 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 two treatment protocols have similar effectiveness in treating major depression.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Non-Invasive Neurostimulation Therapies Centre, University of British Columbia, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • outpatients
  • voluntary and competent to consent
  • Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of MDD, single, recurrent
  • between ages 18-65
  • 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 been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  • have a score of ≥ 18 on the HAMD-17 item
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  • able to adhere to the treatment schedule
  • Pass the TMS adult safety screening (TASS) questionnaire
  • have normal thyroid functioning based on pre-study blood work

Exclusion criteria

  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • have active suicidal intent
  • are pregnant
  • have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
  • have a MINI 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 and causing greater impairment than MDD

Treatment and study plan

HFL rTMS

Device

Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

iTBS

Device

Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

Primary outcomes

  1. HAM-D17 score

    Time frame: baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment

    Outcome measure is measured by a change in the HAM-D17 score from baseline to week 4 or 6. A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study title

A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder

Acronym: HFL vs TBS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 27, 2013
Registry last updated
Jan 30, 2017

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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