Recruitment Challenges for Studies of Deep Brain Stimulation for Treatment-Resistant Depression

Abstract

Rajamannar Ramasubbu,1– 4 Sandra Golding,1,2 Kimberly Williams,1 Aaron Mackie,1 Glenda MacQueen,1,3,4 Zelma HT Kiss1– 4 1Department of Psychiatry, University of Calgary, Calgary, AB, Canada; 2Department of Clinical Neuroscience, University of Calgary, Calgary, AB, Canada; 3Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada; 4Hotchkiss Brain Institute, University of Calgary, Calgary, AB, CanadaCorrespondence: Rajamannar RamasubbuDepartment of Psychiatry/Clinical Neurosciences, University of Calgary, Mathison Centre for Mental Health Research and Education, TRW Building, Room 4D64, 3280 Hospital Drive NW, Calgary, Alberta, T2N4Z6 Tel [phone]Fax [phone]Email [email protected]: Deep brain stimulation (DBS) is currently an investigational treatment for treatment-resistant depression (TRD). There is a need for more DBS trials to strengthen existing evidence of its efficacy for both regulatory and clinical reasons. Recruitment for DBS trials remains challenging due to unproven efficacy in sham-controlled DBS trials, invasive nature of the intervention and stringent eligibility criteria in patient selection. Here, we examined the referral patterns and reasons for exclusion of subjects in our DBS trial.Methods: Data were collected from all patients who expressed interest in participating in a DBS study involving subcallosal cingulate region from 2014 to 2016. Referral sources were categorized as either self-referral or professional referral. Evaluation for eligibility was performed in three stages; initial contact, brief telephone assessment, and in-person psychiatric evaluation. The reasons for exclusion were documented. Descriptive and inferential statistics were used for analysis.Results: Of the 225 patients who contacted us initially, 22 (9.2%) underwent DBS surgery. Self-referral was higher than the referral from professionals (72% versus 28%, P< 0.0001). However, the acceptance rate for surgery was higher among the professional referrals than from self-referrals (40% versus 15%, P=0.03). The common reasons for exclusion were self-withdrawal (38.4%), residing out of province or country (26.1%) and psychiatric/medical comorbidity (21.7%).Conclusion: These findings provide insight into DBS candidacy for future TRD trials. It suggests a need for comprehensive recruitment strategies including active engagement of patients and professionals throughout trials, and effective referral communication with education to optimize recruitment for future DBS trials.Keywords: patient recruitment, deep brain stimulation, treatment-resistant depression, clinical trials, subcallosal cingulate region

Keywords

• deep brain stimulation
• subgenual cingulate region
• treatment resistant depression
• clinical trial
• patient recruitment