NCT02702154

Brief Summary

This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

March 2, 2016

Last Update Submit

March 29, 2018

Conditions

Depression

Keywords

brain stimulationrTMS

Outcome Measures

Primary Outcomes (1)

  • HAM-D17 score

    Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of \<8 is categorized as remission.

    Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment

Secondary Outcomes (2)

  • Beck Depression Inventory-II

    Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment

  • Beck anxiety inventory

    Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment

Other Outcomes (2)

  • Resting-state functional MRI

    1 week pre- and 1 week post-intervention

  • Electroencephalography

    Day 1 and day 15 (final day) of rTMS intervention

Study Arms (3)

High-frequency rTMS

EXPERIMENTAL

20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Device: High-frequency rTMS

Low-frequency rTMS

EXPERIMENTAL

1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Device: Low-frequency rTMS

Sham rTMS

SHAM COMPARATOR

Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Device: Sham rTMS

Interventions

High-frequency rTMSDEVICE

20 Hz active stimulation, twice daily

Also known as: Magventure Cool DB80 Active/Placebo Coil
High-frequency rTMS
Low-frequency rTMSDEVICE

1 Hz active stimulation, twice daily

Also known as: Magventure Cool DB80 Active/Placebo Coil
Low-frequency rTMS
Sham rTMSDEVICE

Sham stimulation, twice daily

Also known as: Magventure Cool DB80 Active/Placebo Coil
Sham rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary and competent to consent to treatment
  • MINI confirmed diagnosis of MDD
  • Outpatient
  • Between the ages of 18-65
  • Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
  • Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
  • Must adhere to study assessment and intervention schedule.
  • Pass the TMS Safety Screening Questionnaire.

You may not qualify if:

  • Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump
  • Have active suicidal intent
  • Are pregnant
  • Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms have a MINI 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 and causing greater impairment than MDD
  • Have received rTMS for any previous indication due to the potential compromise of subject blinding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T2S8, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jonathan Downar, MD PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director, UHN MRI-Guided rTMS Clinic

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 8, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2018

Study Completion

August 1, 2018

Last Updated

March 30, 2018

Record last verified: 2018-03

Locations

CA(1)