Another open labeled trial with rTMS. It is a continuation trial after a recent double-blind placebo controlled trial with rTMS.This study is discussed in a recent post on this blog: Finally some good news about rTMS?
Considering the outcome on the time point at week 4, Dr Shock is not very impressed by the results. For significant difference with the primary outcome 6 patients had to be excluded from the analysis. The mean difference between active and sham on the severity scales is in the range of 2-3 points, significant but hardly clinical relevant.
The NICE guidelines use a difference of 3 point or more as clinical significant.
Another open trial is unethical to my opinion in this stage of development of rTMS.
Patients that were non responders on the double-blind sham controlled rTMS trial received an additional 6 weeks of active rTMS. The nonreponders on the active rTMS group also were continued on rTMS for 6 weeks. Both patients and investigators remained blind to prior treatment condition. The open label study had 2 phases: a 6 week antidepressant medication free acute phase treatment and a 3 week taper phase during which antidepressant medication was initiated. Patients received 5 rTMS sessions per week during 6 weeks followed by 3 times a week in week 7, 2 times a week in week 8 and once a week in the last week.
Patients who received sham in the preceding randomized controlled trial (N = 85), the mean reduction in MADRS scores after 6 weeks of open-label active TMS was -17.0. Further, at 6 weeks, 36 (42.4%) of these patients achieved response on the MADRS, and 17 patients (20.0%) remitted. Remission was defined as a score under 10 on the MADRS. For those patients who received and did not respond to active TMS in the preceding randomized controlled trial (N = 73), the mean reduction in MADRS scores was -12.5, and response and remission rates were 26.0% and 11.0%, respectively.
A well just to let you know, we will wait for another open label trial.
What is interesting to know is that in in the sham to rTMS treatment group, failure to only one antidepressant trial before rTMS resulted in a greater likelihood of response. If resistant to more antidepressants before rTMS predicted less favorable outcome.
When is there going to be a sham controlled trial without medication resistant depressive patients?
You can read the abstract of this article on Therapeutic Neuromodulation Weblog
Avery, D.H. (2008). Transcranial magnetic stimulation in the acute treatment of major depressive disorder: clinical response in an open-label extension trial.. Journal of Clinical Psychiatry, 69(3), 441-451.