Randomized Controlled Trial of Conventional vs Theta Burst rTMS (HFL vs TBS)

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: HFL rTMS

Device: iTBS

Study type

Interventional

Funder types

Other

Identifiers

NCT01887782

179/2012

Details and patient eligibility

About

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.

Enrollment

414 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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