rTMS in Treatment Resistant Depression — rTMSECT  

Depression Clinical Trial

Official title: rTMS in Treatment Resistant Depression

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the safety and efficacy of rTMS as an alternative treatment to ECT. The study will also provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.

Clinical Trial Description

rTMS as an alternative to ECT

Background Electroconvulsive therapy (ECT) is highly effective in the treatment of severe depression (UK ECT Review Group, 2003). During the past decade, transcranial magnetic stimulation has emerged as a new anti-depressant treatment (e.g. Berman et al, 2000). Some randomized trials suggest that repetitive transcranial magnetic stimulation (rTMS) might be as effective as ECT in the treatment of non-psychotic depression (Grunhaus et al, 2000, 2003; Janicak et al, 2002; Rosa et all, 2003; Pridmore et al, 2000; Pridmore, 2000 ). Even at 3 and 6 month follow up, patients treated with rTMS continue to do as well as those treated with ECT (Dannon et al, 2002). A recent review also supported the efficacy of rTMS in treatment resistant depression (Lee et al, 2012). However, other reviews and meta-analyses show only moderate enthusiasm for transcranial magnetic stimulation as an alternative to ECT (e.g. Martin et al, 2003; Schlaepfer et al, 2003) and emphasize the need for further studies.

Given the small number of side effects and comparable efficacy to ECT, we would like to continue investigating rTMS as an alternative to ECT. The study will aim to compare the efficacy of sham vs. active rTMS in patients meeting standard criteria for ECT. In addition, the study will also determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect.

Our sample population will include 40 adult patients from the Emory University Outpatient Psychiatry Department and Atlanta community. Potential subjects may be identified by their treating physicians as potential subjects for the study and after obtaining permission from the patient, the physician will refer the patient to the research coordinator.

Subjects will enter a 4-week fixed-treatment phase and a variable 2-week extension for clinical improvers (defined below). Subject will receive rTMS treatment according the FDA approved protocol with treatments given five times a week daily Monday through Friday at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.

Patients who meet remission criteria (MADRS < 7 for one week, Riedel et al 2010) will be tapered from rTMS. Patients who do not show sufficient improvement at the end of the fixed 4-week period (defined as a < 30% drop from baseline in MADRS scores) will be discontinued. If patients improve sufficiently (i.e., > 30% reduction in MADRS score) but do not meet remission criteria, treatment will continue for up to 2 additional weeks (variable 2-week extension). In the variable phase, the MADRS assessments will be performed twice weekly and improvers, but nonremitters, will continue receiving treatment during the variable 2-week period if they show progressive improvement, defined as at least a 2-point MADRS score reduction at every other rating. The acute trial will be terminated when patients meet the stable remission criteria. The rTMS will then be tapered during a 3-week period.

Data Analysis Dichotomous outcomes (remission, response (defined as a 50% decrease in the baseline MADRS)) will be assessed using a logistic regression model (SAS Institute Inc., Cary, North Carolina) with independent variables of treatment (active vs. sham), medication resistance using the Antidepressant Treatment History Form (ATHF) (low vs. high), current depressive episode duration (log transformed) and age (continuous). The primary analysis will be conducted using the intention-to-treat (ITT) population, defined as all randomized patients who started at least 1 treatment session. All the statistical tests will be performed at the .05 significance level. Interactions were considered significant at the .15 significance level.

A primary purpose of the present study is to determine the safety and efficacy of this trial and provide data for a power analysis to support a larger clinical trial if there is evidence of a clinically relevant treatment effect. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

• NCT number: NCT02080507
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: December 2015