Status:
COMPLETED
Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depressive Disorder
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Ontario Mental Health Foundation
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Major Depressive Disorder (MDD) is one of the most prevalent mental illnesses in North America, in which 30% - 40% fail to respond to conventional treatment. Repetitive Transcranial Magnetic Stimulati...
Detailed Description
Several studies have demonstrated that rTMS is an efficacious treatment for treatment resistant major depressive disorder (TRD). However, recent meta-analyses, and more recent, large, multi-centre stu...
Eligibility Criteria
Inclusion
- voluntary and competent to consent
- diagnosis of MDD, as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV)
- 18 - 85 years of age
- failed to achieve clinical response, or did not tolerate, at least 2 separate antidepressant trials of sufficient dosage for at least 6 wks
- have a score of 20 or greater on the HAM-D17
- have not had an increase or initiation of any psychoactive therapy in the 4 wks prior to testing
- if a woman of childbearing potential, must be on an effective means of birth control
Exclusion
- history of DSM-IV confirmed diagnosis of substance dependence in the last 6 months, or substance abuse in the last month
- concomitant, major, unstable medical or neurologic illness
- history of seizures
- acutely suicidal and/or homicidal
- pregnant
- have metal implants
- history of psychosurgery
- co-morbid diagnosis of borderline and/or antisocial personality disorder. as confirmed by the SCID for Axis II Disorders (SCID-II)
- are currently (or in the past 4 weeks) taking more than 2 mg of lorazepam, or equivalent, daily
- ECT treatment in the current episode
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01515215
Start Date
July 1 2008
End Date
October 1 2016
Last Update
November 1 2016
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4