Deep rTMS for Treatment-Resistant Late-life Depression

This study is currently recruiting participants.
Verified January 2014 by Centre for Addiction and Mental Health
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Brainsway
Information provided by (Responsible Party):
Daniel Blumberger, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01860157
First received: May 18, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the HLPFGDP 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 HLPFGDP coil will result in higher remission rates than placebo stimulation but will have a similar tolerability and safety profile.


Condition Intervention
Major Depressive Disorder
Device: Brainsway HLPFGDP-Coil Deep TMS System (Sham treatment)
Device: Brainsway HLPFGDP-Coil Deep TMS System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of HLPFGDP-Coil rTMS for Treatment-Resistant Late-Life Depression

Resource links provided by NLM:


Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • HDRS-24 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in HDRS-24 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2013
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham HLPFGDP Coil Device: Brainsway HLPFGDP-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 HLPFGDP Device: Brainsway HLPFGDP-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

Detailed Description:

This study is a randomized double blind, sham controlled study to evaluate the safety and efficacy of HLPFGDP-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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01860157

Contacts
Contact: Melissa Daigle 416-535-8501 ext 36434 melissa.daigle@camh.ca

Locations
Canada, Ontario
Centre for Addiction and Mental Health Recruiting
Toronto, Ontario, Canada, M6J 1H4
Principal Investigator: Daniel Blumberger, MD         
Principal Investigator: Zafiris J Daskalakis, MD, PhD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
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
  More Information

No publications provided

Responsible Party: Daniel Blumberger, Clinician Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01860157     History of Changes
Other Study ID Numbers: 107/2011
Study First Received: May 18, 2013
Last Updated: January 9, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Centre for Addiction and Mental Health:
rTMS
depression
magnetic

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014