search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Brainsway H1-Coil Deep TMS System (Sham treatment)
Brainsway H1-Coil Deep TMS System
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring rTMS, depression, magnetic

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham H1 Coil

Active H1

Arm Description

deep rTMS sham treatment

deep rTMS active treatment

Outcomes

Primary Outcome Measures

HDRS-24
Remission defined as HDRS-24 </= 10

Secondary Outcome Measures

Mean change in HDRS-24

Full Information

First Posted
May 18, 2013
Last Updated
May 27, 2017
Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Brainsway
search

1. Study Identification

Unique Protocol Identification Number
NCT01860157
Brief Title
Deep rTMS for Treatment-Resistant Late-life Depression
Acronym
rTMS
Official Title
A Randomized Controlled Study of H1-Coil rTMS for Treatment-Resistant Late-Life Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Canadian Institutes of Health Research (CIHR), Brainsway

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
rTMS, depression, magnetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham H1 Coil
Arm Type
Sham Comparator
Arm Description
deep rTMS sham treatment
Arm Title
Active H1
Arm Type
Active Comparator
Arm Description
deep rTMS active treatment
Intervention Type
Device
Intervention Name(s)
Brainsway H1-Coil Deep TMS System (Sham treatment)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Brainsway H1-Coil Deep TMS System
Intervention Description
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
Primary Outcome Measure Information:
Title
HDRS-24
Description
Remission defined as HDRS-24 </= 10
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Mean change in HDRS-24
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel M. Blumberger, MD, FRCPC
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zafiris J Daskalakis, Md, FRCPC
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Deep rTMS for Treatment-Resistant Late-life Depression

We'll reach out to this number within 24 hrs