Pilot Study Comparing 10hz vs Theta Burst Stimulation

Major Depressive Disorder Clinical Trial

Official title:

Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800226
• Other study ID #: H13-02340
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: May 2015

Study information

• Verified date: August 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• 10Hz
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
• iTBS
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

Locations

Country	Name	City	State
Canada	Non-Invasive Neurostimulation Therapies lab, University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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

External Links

•   Laboratory Website