BROADEN Trial of DBS for Treatment-Resistant Depression No Better than Sham

Website for theBROADEN™ study, which was terminated by thesponsor.A multi-site, randomized, double-blind, placebo-controlled clinical trial ofdeep brain stimulation (DBS) for treatment-resistant depression has failed, according to a new article inLancet Psychiatry. The targeted brain region was bilateralsubcallosal cingulate white matter, which had been called the “Depression Switch” based on acute stimulation studies at Emory. These disappointing results were not surprising, since they were covered byNeurotech Business Report in December 2013 and then in depth by my postshere andhere. The new paper followed the patients for a longer period of time, up to 24 months for some in the cohort.The main portion of the trial was six months in length. All patients received implantation surgery. Two weeks later, they were randomized to either the treatment group (n=60), who received stimulation right away, or the “sham” control group (n=30), who did not. After six months, the blinding was uncovered and both sham and treatment groups were offered open label DBS for another six months.In the figure below, Control (red line) and Stimulation (blue line) groups both showed slight improvements over time, with no significant difference in depression severity measured by the Montgomery- Åsberg Depression Rating Scale (MADRS). This was the primary endpoint. We don ' t see a difference between groups at six months or any other time.- click on image for a larger view -Fig. 2. (Holtzhei...
Source: The Neurocritic - Category: Neuroscience Authors: Source Type: blogs