ClinicalTrials.gov
ClinicalTrials.gov Menu

Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression (OFC-rTMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797210
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Device: Continuous theta-burst stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Orbital Frontal Cortex Repetitive Transcranial Magnetic Stimulation Magnetic Stimulation in the Treatment of Refractory Depression
Study Start Date : June 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 17-Item Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: Baseline, after each week of treatment (i.e. after 5 days of treatment) and at 1, 4, and 12 weeks post-treatment. ]
    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.


Secondary Outcome Measures :
  1. Beck Depression Inventory-II (BDI-II) [ Time Frame: Daily for 6 weeks ]

Other Outcome Measures:
  1. Magnetic Resonance Imaging (MRI) [ Time Frame: 1 week pre- and 1 week post-treatment ]
    10 min resting-state functional MRI (rs-fMRI) at 3 Tesla (3T)

  2. Electroencephalography (EEG) [ Time Frame: Day 1 (First day of treatment), Day 15, and Day 30 (Final day of treatment)] ]
    10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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).

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): NCT02797210


Locations
Canada, Ontario
UHN MRI-Guided rTMS Clinic, Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Canadian Institutes of Health Research (CIHR)

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02797210     History of Changes
Other Study ID Numbers: 16-5094
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders