Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression

NCT02797210 | Completed

• 1 other identifier: 16-5094
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

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.

  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)

  Daily for 6 weeks

Other Outcomes (2)

• Magnetic Resonance Imaging (MRI)

  1 week pre- and 1 week post-treatment

• Electroencephalography (EEG)

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

Study Arms (2)

Sham then Active Stimulation

EXPERIMENTAL

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

Active then Sham Stimulation

EXPERIMENTAL

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

Continuous theta-burst stimulation DEVICE

Active then Sham Stimulation; Sham then Active Stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

UHN MRI-Guided rTMS Clinic, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)