Pilot Study Comparing 10hz vs Theta Burst Stimulation

Phase 3

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: iTBS; Device: 10Hz

• Registration Number: NCT02800226
• Lead Sponsor: University of British Columbia

Brief Summary

This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• outpatients
• voluntary and competent to consent
• Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
• 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 episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
• have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-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

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Exclusion Criteria

• have a history 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 diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iTBS	iTBS	intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks
10Hz	10Hz	High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks

Primary Outcome Measures

Name	Time	Method
Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score	baseline, 1, 4, and 12 weeks post-treatment	A 50% improvement in the score is considered response to rTMS. A final score of \<8 is categorized as remission.

Trial Locations

Locations (1)

Non-Invasive Neurostimulation Therapies lab, University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada