Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

Center for Addiction and Mental Health (CAMH)

Status: Completed

Conditions: Major Depression

Treatments: Device: LFR followed by HFL; Device: cTBS followed by iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT02998580

076-2016

Details and patient eligibility

About

This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices 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 bilateral theta burst protocol has similar effectiveness to the conventional bilateral rTMS protocol in treating major depression.

Enrollment: 163 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• are an outpatient
• are ≥60 years old
• have a Mini-International Neuropsychiatric Interview (MINI 6.0)67 confirmed diagnosis of MDD, with a current MDE
• have 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 failed to tolerate two separate trials of an antidepressant
• have a score > 17 on the MADRS
• have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
• have normal electrolytes, hemoglobin and thyroid functioning based on pre-study blood work
• Pass the TMS adult safety screening (TASS) questionnaire
• Are able to have an MRI

Exclusion criteria

• have a history of substance dependence or abuse within the last 3 months
• have a concomitant major unstable medical illness determined by one of the study physicians
• have active suicidal intent
• have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder
• have current psychotic symptoms
• have a 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. One of these comorbidities will not be exclusionary if they are not deemed to be primary.
• have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
• have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10.
• did not respond to a course of ECT in the current depressive episode
• have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible
• have a history of a primary seizure disorder or a seizure associated with an intracranial lesion.
• have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
• have a implanted electronic device that is currently function such as a defibrillator
• currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant
• if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study
• non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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163 participants in 2 patient groups

Convential Sequential Bilateral rTMS

Active Comparator group

Description:

LFR followed by HFL. 1 Hz stimulation of the right DLPFC for 600 pulses followed by 10 Hz stimulation of the left DLPFC for 3000 pulses (4 seconds on 26 seconds off for 75 trains). Treatment will occur 5 times per week for 4 to 6 weeks.

Treatment:

Device: LFR followed by HFL

Bilateral Theta Burst Stimulation

Experimental group

Description:

cTBS followed by iTBS. continuous theta burst stimulation (cTBS) of the right DLPFC for 600 pulses followed by intermittent theta burst stimulation (iTBS) of the left DLPFC for 600 pulses. Treatment will occur 5 times per week for 4 to 6 weeks.

Treatment:

Device: cTBS followed by iTBS