Randomized Controlled Trial of Conventional vs Theta Burst rTMS

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: HFL rTMS; Device: iTBS

• Registration Number: NCT01887782
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-06-25
• Study First Posted: 2013-06-27
• Study Start: 2013-09
• Primary Completion: 2016-07
• Study Completion: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HFL rTMS	HFL rTMS	High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
iTBS	iTBS	intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks

Primary Outcome Measures

Name	Time	Method
HAM-D17 score	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.

Trial Locations

Locations (3)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada

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