Major Depressive DisorderrTMSNCT01860157

Deep rTMS for Treatment-Resistant Late-life Depression

A study testing Brainsway H1-Coil Deep TMS System in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 60 to 85 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Brainsway H1-Coil Deep TMS System
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 58 participants
Where: 1 siteCanada
Study dates: Jun 2013to Dec 2016
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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

Show all 17Show fewer

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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions: Major Depressive Disorder
Being tested: Brainsway H1-Coil Deep TMS System (Sham treatment), Brainsway H1-Coil Deep TMS System
Keywords: rTMS, depression, magnetic
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brainsway H1-Coil Deep TMS System (Sham treatment)Device
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.
Brainsway H1-Coil Deep TMS SystemDevice
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

Study groups in NCT01860157
Study group	Role	What they receive
Sham H1 Coil	Sham comparator	deep rTMS sham treatment Receives: Device: Brainsway H1-Coil Deep TMS System (Sham treatment)
Active H1	Active comparator	deep rTMS active treatment Receives: Device: Brainsway H1-Coil Deep TMS System

What is being measured

The primary outcome is the main question the study is designed to answer.

HDRS-24
Remission defined as HDRS-24 </= 10
Measured: 4 weeks

Secondary outcomes (1)

Mean change in HDRS-24
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Dec 2016

First posted22 May 2013 (estimated)
Study startJun 2013
Primary completionNov 2016
Study completionDec 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01860157
Sponsor's protocol ID: 107/2011
Acronym: rTMS
Status last verified: May 2017
First submitted: 18 May 2013
Last updated: 31 May 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)

All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study of H1-Coil rTMS for Treatment-Resistant Late-Life Depression
ClinicalTrials.gov ID: NCT01860157
Acronym / sponsor ID: rTMS / 107/2011
Conditions: Major Depressive Disorder
Keywords: rTMS, depression, magnetic
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Centre for Addiction and Mental HealthUniversity, hospital or other
Collaborators: Canadian Institutes of Health Research (CIHR), Brainsway
Study start: Jun 2013
Primary completion: Nov 2016 (actual)
Study completion: Dec 2016 (actual)
First posted: 22 May 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sham H1 Coil	Sham comparator	Device: Brainsway H1-Coil Deep TMS System (Sham treatment)deep rTMS sham treatment
Active H1	Active comparator	Device: Brainsway H1-Coil Deep TMS Systemdeep rTMS active treatment

Who may qualify

Ages: 60 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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)

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Sham H1 Coil
Brainsway H1-Coil Deep TMS SystemDeep 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	Device	Active H1

Primary outcome

HDRS-24
Time frame: 4 weeks
Remission defined as HDRS-24 </= 10

1 secondary outcome

Mean change in HDRS-24
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.

Related trials for Major Depressive Disorder

RecruitingPhase 1
Open-Label Psilocybin Study in Transdiagnostic Population
Transdiagnostic, Depression - Major Depressive Disorder
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
RecruitingPhase 2
A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
RecruitingPhase 1
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
Depression, Major Depressive Disorder
Not yet recruiting
Acceptance and Committment Therapy Combined With Ketamine in Difficult-to-Treat Depression.
Major Depressive Disorder (MDD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel M. Blumberger, MD, FRCPC principal investigator

Centre for Addiction and Mental Health

Zafiris J Daskalakis, Md, FRCPC principal investigator

Centre for Addiction and Mental Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brainsway H1-Coil Deep TMS System in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HDRS-24 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860157.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.