Back to resultsAccelerated rTMS for Treatment-Resistant Major Depression
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
- Baseline score ≥ 13 on the QIDS-C
- Stable medication regimen (>= 4 weeks) prior to study enrolment
Exclusion Criteria:
- Psychotic features in the current episode
- Lifetime history of psychotic disorders and/or bipolar I or II disorders
- Substance or alcohol abuse/dependence in the past 6 months
- Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
- Uncontrolled medical disease (e.g., cardiovascular, renal)
- Pregnancy and/or lactation
- Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)
- Hearing loss
Sites / Locations
- Douglas Mental Health University Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Accelerated HF-rTMS
Arm Description
Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
Outcomes
Primary Outcome Measures
Quick Inventory of Depressive Symptomatology - Clinician Version
Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score ≤ 5.
Secondary Outcome Measures
Full Information
NCT ID
NCT02125799
First Posted
April 25, 2014
Last Updated
October 2, 2014
Sponsor
Douglas Mental Health University Institute
1. Study Identification
Unique Protocol Identification Number
NCT02125799
Brief Title
Accelerated rTMS for Treatment-Resistant Major Depression
Official Title
A Pilot Trial on the Effectiveness and Tolerability of Accelerated High Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Douglas Mental Health University Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks. Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have significant advantages in terms of access, patient acceptance and costs. In the present open label trial the investigators intend to assess the effectiveness and acceptability of a novel aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day). For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well as with computerized neurocognitive tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accelerated HF-rTMS
Arm Type
Experimental
Arm Description
Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
Intervention Type
Device
Intervention Name(s)
Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
Intervention Description
Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
Primary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Clinician Version
Description
Response to treatment is defined as a ≥ 50% reduction in the scores of the QIDS-C. Remission is defined as a QIDS-C score ≤ 5.
Time Frame
Week 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Presence of a current major depressive disorder (according to the DSM-IV-TR) that has not improved after ≥ 2 adequate antidepressant trial(s) in the current episode;
Baseline score ≥ 13 on the QIDS-C
Stable medication regimen (>= 4 weeks) prior to study enrolment
Exclusion Criteria:
Psychotic features in the current episode
Lifetime history of psychotic disorders and/or bipolar I or II disorders
Substance or alcohol abuse/dependence in the past 6 months
Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
Uncontrolled medical disease (e.g., cardiovascular, renal)
Pregnancy and/or lactation
Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy, metallic head implant)
Hearing loss
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Berlim, MD, MSc
Organizational Affiliation
McGill University - Dept of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Douglas Mental Health University Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H1R3
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Accelerated rTMS for Treatment-Resistant Major Depression
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