Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

Study Overview
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Brief Summary
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This trial will compare conventional sequential bilateral rTMS to a bilateral theta burst stimulation protocol. The right and left dorsolateral prefrontal cortices will be the site of stimulation in both treatment conditions. The site of stimulation will be targeted using MRI co-registration. The study seeks to determine if the bilateral theta burst protocol has similar effectiveness to the conventional bilateral rTMS protocol in treating major depression.

Official Title
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Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression

Conditions
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Major Depression

Intervention / Treatment
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* Device: LFR followed by HFL
* Device: cTBS followed by iTBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are an outpatient are ≥60 years old have a Mini-International Neuropsychiatric Interview (MINI 6.0)67 confirmed diagnosis of MDD, with a current MDE have failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of > 3 in the current episode or have failed to tolerate two separate trials of an antidepressant have a score > 17 on the MADRS have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening have normal electrolytes, hemoglobin and thyroid functioning based on pre-study blood work Pass the TMS adult safety screening (TASS) questionnaire Are able to have an MRI Exclusion Criteria: have a history of substance dependence or abuse within the last 3 months have a concomitant major unstable medical illness determined by one of the study physicians have active suicidal intent have a lifetime MINI diagnosis of bipolar I or II disorder, or primary psychotic disorder have current psychotic symptoms have a 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), or dysthymia, assessed by a study investigator to be primary. One of these comorbidities will not be exclusionary if they are not deemed to be primary. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD have presumed or probable dementia or clinical evidence of dementia as assessed by a Short Blessed Test score of greater than 10. did not respond to a course of ECT in the current depressive episode have received rTMS in the current episode, patients who have had rTMS in a previous episode would be eligible have a history of a primary seizure disorder or a seizure associated with an intracranial lesion. 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 have a implanted electronic device that is currently function such as a defibrillator currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant 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 non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Convential Sequential Bilateral rTMS<br>LFR followed by HFL. 1 Hz stimulation of the right DLPFC for 600 pulses followed by 10 Hz stimulation of the left DLPFC for 3000 pulses (4 seconds on 26 seconds off for 75 trains). Treatment will occur 5 times per week for 4 to 6 weeks. | Device: LFR followed by HFL<br>* Magventure Cool B70 Coil with RX100 Stimulator<br>|
| Experimental: Bilateral Theta Burst Stimulation<br>cTBS followed by iTBS. continuous theta burst stimulation (cTBS) of the right DLPFC for 600 pulses followed by intermittent theta burst stimulation (iTBS) of the left DLPFC for 600 pulses. Treatment will occur 5 times per week for 4 to 6 weeks. | Device: cTBS followed by iTBS<br>* Magventure Cool B70 Coil with RX100 Stimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on the Montgomery Asberg Depression Rating Scale (MADRS) | Change from baseline to week 4 or 6 endpoint | After 4 or 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission on the MADRS | Score less than or equal to 10 | After 4 or 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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late-life depression, treatment resistance