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Trial record 13 of 1333 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"

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

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ClinicalTrials.gov Identifier: NCT02998580
Recruitment Status : Recruiting
First Posted : December 20, 2016
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
Daniel Blumberger, Centre for Addiction and Mental Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depression Device: LFR followed by HFL Device: cTBS followed by iTBS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conventional Bilateral rTMS vs. Bilateral Theta Burst Stimulation for Late-Life Depression
Study Start Date : December 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Convential Sequential Bilateral rTMS

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
Magventure Cool B70 Coil with RX100 Stimulator

Experimental: Bilateral Theta Burst Stimulation

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
Magventure Cool B70 Coil with RX100 Stimulator




Primary Outcome Measures :
  1. Change on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: After 4 or 6 weeks ]
    Change from baseline to week 4 or 6 endpoint


Secondary Outcome Measures :
  1. Remission on the MADRS [ Time Frame: After 4 or 6 weeks ]
    Score less than or equal to 10



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998580


Contacts
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Contact: Elizabeth Hollingdrake 416-535-8501 ext 33494 elizabeth.hollingdra@camh.ca

Locations
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Canada, Ontario
CAMH Recruiting
Toronto, Ontario, Canada, M6J1H4
Contact: Elizabeth Hollingdrake    416-535-8501    elizabeth.hollingdra@camh.ca   
Principal Investigator: Daniel M. Blumberger, MD         
Sponsors and Collaborators
Centre for Addiction and Mental Health
University Health Network, Toronto
Investigators
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Principal Investigator: Daniel M. Blumberger, MD CAMH

Additional Information:
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Responsible Party: Daniel Blumberger, Principal Investigator, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02998580     History of Changes
Other Study ID Numbers: 076-2016
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Daniel Blumberger, Centre for Addiction and Mental Health:
late-life depression
treatment resistance
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders