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Completed

NCT Number: NCT02797210

Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHN MRI-Guided rTMS Clinic, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • have a MINI-International Neuropsychiatric (MINI) confirmed diagnosis of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • have active suicidal intent
  • are pregnant
  • 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
  • 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 a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD
  • have failed a course of electroconvulsive therapy (ECT) in the current episode or previous episode
  • 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
  • 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
  • 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
  • clinically significant laboratory abnormality, in the opinion of the study investigator
  • 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
  • non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).

Treatment and study plan

Continuous Theta-burst Stimulation

Device

Primary outcomes

  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 outcomes

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

    Time frame: Daily for 6 weeks

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Efficacy of Orbital Frontal Cortex Repetitive Transcranial Magnetic Stimulation Magnetic Stimulation in the Treatment of Refractory Depression

Acronym: OFC-rTMS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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