Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression

NCT ID: NCT02797210

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Continuous theta-burst stimulation

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Continuous theta-burst stimulation

Intervention Type: DEVICE

Interventions

Continuous theta-burst stimulation

Intervention Type: DEVICE

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UHN MRI-Guided rTMS Clinic, Toronto Western Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

16-5094

Identifier Type: -

Identifier Source: org_study_id