A medical device company launched a multi-site study in the US to confirm the efficacy of its novel non-invasive device for treating Major Depressive Disorder (MDD). The goal was to see if the novel device was equal or superior to the FDA-cleared earlier version of the device. The sponsor’s goal was to recruit 123 participants overall. In one year, the study only managed to recruit 22 patients. nRollmed was hired to help several of the struggling sites to recruit. The major challenge was the stringent criteria in the protocol. Patients needed to be experiencing an active depressive episode. They also needed to have no cardiac or neurological issues. In addition, migraines were not allowed, which eliminated many interested patients. In addition, patients needed to be resistant to at least one depression treatment, but also needed to be stable on their current treatment for at least 2 months. Another major challenge was that common comorbidities such as anxiety disorder, bipolar, OCD, PTSD, eating or personality disorders were not allowed. Finally, patients were asked to attend visits 5 days a week which was a difficult time commitment.
