Case Study

Major Depressive Disorder (MDD)

Medical Device Company Tests Treatment for MDD
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.
Customized and Collaborative Approach
nRollmed’s recruitment strategy was to increase awareness of the study in an online campaign driving people to learn more on a  custom-built website. Patients were interviewed by a dedicated pre-screening team to make sure they met the initial criteria for joining, before being referred to the nearest site for a screening visit. Each site was provided with  management platform to make it easy for sites to manage patient referrals. The platform also allowed the sponsor to understand each site’s progress. Site support was an equally important aspect for successful recruitment. The nRollmed team built strong relationships with staff at each site, identified their specific challenges, and learned their preferences, availability, and capacity for receiving patient referrals. nRollmed’s team then tailored the service to each site’s needs. nRollmed conducted regular calls with sites, which helped iron out issues and kept the study front-of-mind for the sites. nRollmed also helped reduce the sites’ workload by helping them reach patients for scheduling and sending appointment reminders.
The nRollmed Method
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Over the 12 months working on the study, 40 patients from nRollmed were randomized. This accounted for 40% of all patients recruited in the time nRollmed was active. Overall, nRollmed’s patients made up 32% of the study’s total randomizations. With nRollmed’s help, the study completed recruitment 13 months early.

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nRollmed patients randomized
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Monthly randomizations tripled
months recruitment time saved

nRollmed recruited 40% of all patients needed.

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