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OpenTrials
Completed

NCT Number: NCT02800226

Pilot Study Comparing 10hz vs Theta Burst Stimulation

This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Non-Invasive Neurostimulation Therapies lab, University of British Columbia

Vancouver, British Columbia, V6T2A1, Canada

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 Major Depressive Disorder (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 Hamilton Depression Rating Score 17-item (HDRS-17)
  • 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

10Hz

Device

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

iTBS

Device

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

Primary outcomes

  1. Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score

    Time frame: baseline, 1, 4, and 12 weeks post-treatment

    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

University of British Columbia

Other

Registry information

Official study title

Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 15, 2016
Registry last updated
Aug 10, 2018

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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