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

C

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

414 participants in 2 patient groups

HFL rTMS
Experimental group
Description:
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4 weeks
Treatment:
Device: HFL rTMS
iTBS
Active Comparator group
Description:
intermittent Theta Burst Stimulation (iTBS) five days per week for 4 weeks
Treatment:
Device: iTBS

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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