Randomized Controlled Trial of Conventional vs Theta Burst rTMS

Major Depressive Disorder Clinical Trial

— HFL vs TBS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887782
• Other study ID #: 179/2012
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: January 26, 2017
• Start date: September 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• HFL rTMS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
• iTBS
Magventure Cool B70 Coil with either RX100 or RX30 Stimulator

Locations

Country	Name	City	State
Canada	Centre for Addiction and Mental Health	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	Non-Invasive Neurostimulation Therapies Centre, University of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAM-D17 score	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.	baseline, after each 5 treatment sessions, and 1, 4, and 12 weeks post-treatment