NCT02800226

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3 major-depressive-disorder

Timeline
Completed

Started Mar 2014

Shorter than P25 for phase_3 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

June 10, 2016

Last Update Submit

August 8, 2018

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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

    A 50% improvement in the score is considered response to rTMS. A final score of \<8 is categorized as remission.

    baseline, 1, 4, and 12 weeks post-treatment

Study Arms (2)

10Hz

EXPERIMENTAL

High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks

Device: 10Hz

iTBS

ACTIVE COMPARATOR

intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks

Device: iTBS

Interventions

10HzDEVICE

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

10Hz
iTBSDEVICE

Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

iTBS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Non-Invasive Neurostimulation Therapies lab, University of British Columbia

Vancouver, British Columbia, V6T2A1, Canada

Location

Related Publications (2)

  • Ge R, Downar J, Blumberger DM, Daskalakis ZJ, Vila-Rodriguez F. Functional connectivity of the anterior cingulate cortex predicts treatment outcome for rTMS in treatment-resistant depression at 3-month follow-up. Brain Stimul. 2020 Jan-Feb;13(1):206-214. doi: 10.1016/j.brs.2019.10.012. Epub 2019 Oct 18.

    PMID: 31668646DERIVED

  • Shalbaf R, Brenner C, Pang C, Blumberger DM, Downar J, Daskalakis ZJ, Tham J, Lam RW, Farzan F, Vila-Rodriguez F. Non-linear Entropy Analysis in EEG to Predict Treatment Response to Repetitive Transcranial Magnetic Stimulation in Depression. Front Pharmacol. 2018 Oct 30;9:1188. doi: 10.3389/fphar.2018.01188. eCollection 2018.

    PMID: 30425640DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Fidel Vila-Rodriguez, MD

    University of British Columia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

June 10, 2016

First Posted

June 15, 2016

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

CA(1)