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CompletedNCT02797210OFC-rTMSUpdated May 3, 2018

Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression

An interventional study of Continuous theta-burst stimulation in Depression, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-03.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This trial will compare the efficacy of active inhibitory OFC-rTMS to sham OFC-rTMS in major depression. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 32 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. are outpatients
  2. are voluntary and competent to consent to treatment
  3. have a Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of major depressive disorder (MDD), single or recurrent
  4. are between the ages of 18 and 65
  5. 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
  6. have a score > 18 on the HAMD-17
  7. have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening
  8. able to adhere to the treatment schedule
  9. Pass the TMS adult safety-screening (TASS) questionnaire
  10. have normal thyroid functioning based on pre-study blood work.

Exclusion criteria

Exclusion Criteria:

  1. have a MINI-International Neuropsychiatric (MINI) confirmed diagnosis of substance dependence or abuse within the last 3 months
  2. have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  3. have active suicidal intent
  4. are pregnant
  5. have a lifetime Mini-International Neuropsychiatric Interview (MINI) diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
  6. 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
  7. have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  8. have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
  9. have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
  10. 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
  11. 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
  12. clinically significant laboratory abnormality, in the opinion of the study investigator
  13. currently (or in the last 4 weeks) take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy
  14. non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Sham then Active Stimulation

    Sham repetitive transcranial magnetic stimulation (rTMS) to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks, then active rTMS to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks

    Device: Continuous theta-burst stimulation

  • Experimental
    Active then Sham Stimulation

    Active repetitive transcranial magnetic stimulation (rTMS) to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks, then sham rTMS to right orbitofrontal cortex, twice daily, 5 days per week for 3 weeks

    Device: Continuous theta-burst stimulation

Interventions

  • DeviceContinuous theta-burst stimulation
06

What researchers measure

Primary outcomes

  1. 17-Item Hamilton Rating Scale for Depression (HAMD-17)

    Outcome measured by a change in HAMD-17 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.

    Time frame: Baseline, after each week of treatment (i.e. after 5 days of treatment) and at 1, 4, and 12 weeks post-treatment.

Secondary outcomes

  1. Beck Depression Inventory-II (BDI-II)

    Time frame: Daily for 6 weeks

Other outcomes

  1. Magnetic Resonance Imaging (MRI)

    10 min resting-state functional MRI (rs-fMRI) at 3 Tesla (3T)

    Time frame: 1 week pre- and 1 week post-treatment

  2. Electroencephalography (EEG)

    10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions

    Time frame: Day 1 (First day of treatment), Day 15, and Day 30 (Final day of treatment)]

07

Study locations

1 site
  • UHN MRI-Guided rTMS Clinic, Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02797210
Lead sponsor
University Health Network, Toronto
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Sponsor
First posted
Jun 13, 2016
Start date
Jun 2016
Primary completion
Jul 2017
Completion
Jul 2017
Last update
May 3, 2018

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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