Deep rTMS for Treatment-Resistant Late-life Depression

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Major Depressive Disorder

Treatments

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

Device: Brainsway H1-Coil Deep TMS System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01860157

107/2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No 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)