Deep rTMS for Treatment-Resistant Late-life Depression (rTMS)

A Randomized Controlled Study of H1-Coil rTMS for Treatment-Resistant Late-Life Depression

In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left DLPFC. The investigators propose that active stimulation with the H1 coil will result in higher remission rates than placebo stimulation but will have a similar tolerability and safety profile.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Brainsway H1-Coil Deep TMS System (Sham treatment); Device: Brainsway H1-Coil Deep TMS System

Detailed Description

This study is a randomized double blind, sham controlled study to evaluate the safety and efficacy of H1-coil rTMS as a treatment for patients over 60 years of age with major depressive disorder who have not tolerated or failed to respond to antidepressant medications. The study duration is 4-6 weeks in length. The acute phase is 4 weeks of 5 daily treatments followed by 2 weeks of biweekly treatment if remission is achieved at the 4 week mark. Symptom change and remission criteria will be assessed using the HRDS-24 item. Cognition will be assessed using a validated battery.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H4
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• outpatients
• voluntary and competent to consent to treatment
• SCID for DSM-IV confirmed diagnosis of major depressive disorder, single or recurrent
• between the ages of 60 and 85
• failed to achieve a clinical response to an adequate dose of an antidepressant based on an 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)
• a score of ≥ 22 on the HDRS-24
• 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 safety screening questionnaire
• have normal thyroid functioning based on pre-study blood work

Exclusion Criteria:

• history of DSM-IV substance dependence or abuse within the last 3 months
• concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
• acutely suicidal
• pregnant
• lifetime SCID diagnosis of Bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
• SCID 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) assessed by a study investigator to be primary and causing greater impairment than MDD
• SCID diagnosis of any personality disorder and assessed by a study investigator to be primary and causing greater impairment than MDD
• have presumed or probably dementia, as defined by Mini Mental Status Exam (MMSE)<26 and clinical evidence of dementia
• failed a course of ECT within the current depressive episode
• a significant neurological disorder or insult, including, but no limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
• on a dose of Buprioprion greater than 300mg per day
• 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
• 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
• clinically significant laboratory abnormality, in the opinion of the investigator
• currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
• inability to communicate in English
• non-correctable clinically significant sensory impairment (i.e cannot hear well enough to cooperate with interview)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham H1 Coil; deep rTMS sham treatment	Device: Brainsway H1-Coil Deep TMS System (Sham treatment); In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
Active Comparator: Active H1; deep rTMS active treatment	Device: Brainsway H1-Coil Deep TMS System; Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HDRS-24	Remission defined as HDRS-24 </= 10	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change in HDRS-24	4 weeks

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: Canadian Institutes of Health Research (CIHR); Brainsway
• Investigators: Principal Investigator: Daniel M. Blumberger, MD, FRCPC, Centre for Addiction and Mental Health; Principal Investigator: Zafiris J Daskalakis, Md, FRCPC, Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: May 18, 2013
• First Submitted That Met QC Criteria: May 18, 2013
• First Posted (Estimate): May 22, 2013

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 27, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: depression; rTMS; magnetic
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 107/2011