Examining the Efficacy of Orbitofrontal Cortex rTMS for Depression

Depression Clinical Trial

— OFC-rTMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797210
• Other study ID #: 16-5094
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: June 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Continuous theta-burst stimulation

Locations

Country	Name	City	State
Canada	UHN MRI-Guided rTMS Clinic, Toronto Western Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Magnetic Resonance Imaging (MRI)	10 min resting-state functional MRI (rs-fMRI) at 3 Tesla (3T)	1 week pre- and 1 week post-treatment
Other	Electroencephalography (EEG)	10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions	Day 1 (First day of treatment), Day 15, and Day 30 (Final day of treatment)]
Primary	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	Beck Depression Inventory-II (BDI-II)		Daily for 6 weeks