Deep rTMS for Treatment-Resistant Late-life Depression

NCT01860157 | Completed

• 1 other identifier: 107/2011
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

rTMS; depression; magnetic

Outcome Measures

Primary Outcomes (1)

• HDRS-24

  Remission defined as HDRS-24 \</= 10

  4 weeks

Secondary Outcomes (1)

• Mean change in HDRS-24

  4 weeks

Study Arms (2)

Sham H1 Coil

SHAM COMPARATOR

deep rTMS sham treatment

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

Active H1

ACTIVE COMPARATOR

deep rTMS active treatment

Device: Brainsway H1-Coil Deep TMS System

Interventions

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.

Sham H1 Coil

Brainsway H1-Coil Deep TMS System DEVICE

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

Active H1

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Brainsway: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Daniel M. Blumberger, MD, FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

• Zafiris J Daskalakis, Md, FRCPC

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: May 18, 2013
• First Posted: May 22, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

CA (1)