Major Depressive Disorder Clinical Trial
Official title:
Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depressive Disorder
Verified date | October 2016 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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 Stimulation (rTMS) has been shown to be an effective therapeutic tool for the treatment of MDD. This form of treatment involves a series of magnetic pulses directed to the brain for about 30 minutes. Importantly, such treatment is very safe and well tolerated. However, to date, most treatment studies show modest efficacy due to limitations, including: 1) treatments that are delivered to only one side of the brain; 2) treatment that does not directly target a specific brain region associated with depression; 3) treatments that are of short duration; 4) treatments that are of insufficient intensity; and 5) insufficient understanding of the brain mechanisms responsible for therapeutic effect. This study is designed to directly address all of these limitations, as well as explore brain mechanisms (e.g. cortical excitability) through which treatment is optimized.
Status | Completed |
Enrollment | 107 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Ontario Mental Health Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Degree of Change in HAM-D17 Scores | At weeks 3 and/or 6 | No | |
Secondary | Degree of Change in Montgomery-Asberg Depression Rating Scale Scores | At weeks 3 and/or 6 | No | |
Secondary | Degree of Change in Beck Depression Inventory Scores | At weeks 3 and/or 6 | No | |
Secondary | Degree of Change in Brief Psychiatric Ratings Scale Scores | At weeks 3 and/or 6 | No | |
Secondary | Changes in Cortical Excitability | Assessed via TMS-EEG protocol. | At weeks 3 and/or 6 | No |
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