Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments hfl rtms, itbs
Phase phase 3
Sponsor Centre for Addiction and Mental Health
Collaborator University Health Network, Toronto
Start date September 2013
End date July 2016
Trial size 450 participants
Trial identifier NCT01887782, 179/2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
hfl rtms
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
(Active Comparator)
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
itbs
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

Primary Outcomes

Measure
HAM-D17 score
time frame: baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Randomized Controlled Study of Conventional Versus Theta Burst Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depressive Disorder
Principal investigator Daniel Blumberger, MD, MSc
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Centre for Addiction and Mental Health.