Eleven consecutive patients with severe, chronic TRD were enrolled in a research protocol at Emory University testing safety and efficacy of SCC DBS for TRD (clinicaltrials.gov NCT00367003). Participants provided written informed consent to participate. The protocol was approved by the Emory University Institutional Review Board and the US Food and Drug Administration under an Investigational Device Exemption (G060028 held by H.S.M.) and is monitored by the Emory University Department of Psychiatry and Behavioral Sciences Data and Safety Monitoring Board.
The inclusion and exclusion criteria were essentially identical to those previously published by Holtzheimer et al. describing the first seventeen subjects implanted at Emory University (15 (link)). Key inclusion criteria consisted of: 18 to 70 years-old with a diagnosis of major depressive disorder (confirmed with the Structured Clinical Interview for DSM-IV and by the study psychiatrists (PRP, SJG, PEH, ALC)); a current depressive episode of at least 12 months without significant response to at least 4 adequate antidepressant treatments (scoring 3 or higher on the Antidepressant Treatment History Form and verified through medical records); lifetime failure or intolerance of electroconvulsive therapy or inability to receive electroconvulsive therapy; average score ≥ 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17) averaged over the four weeks prior to surgery; Global Assessment of Functioning (GAF) of 50 or less; capacity to provide informed consent; and being able to relocate to the Atlanta area for 7 months (26 –29 ).
Key exclusion criteria were defined as: clinically significant medical or psychiatric comorbidity (including personality disorders as determined by a review of medical records, the Structured Clinical Interview-II, and clinical examination); active substance use disorder; active suicidal ideation with plan or intent, a suicide attempt within the past 6 months, or more than 2 suicide attempts within the past 2 years; pregnancy or planning to become pregnant during the study; or contraindication for DBS surgery or chronic stimulation.
The preoperative evaluation lasted a minimum of 4 weeks. Chronic stimulation was initiated 4 weeks following surgery. Outcome was assessed weekly for 24 weeks of active stimulation using the HDRS-17. Response to treatment was defined as at least a 50% decrease and remission as 7 points or less on the HDRS-17 at 24 weeks. For any missing timepoint the previous observation was carried forward to the next timepoint. Medication changes were not allowed during the preoperative evaluation phase or the initial 24 weeks of chronic DBS. All patients received cognitive behavioral therapy. Patients were aware that they were receiving active stimulation, but were not privy to the criteria for target identification, contact selection or dose increases. All procedures were carried out at Emory University.
The inclusion and exclusion criteria were essentially identical to those previously published by Holtzheimer et al. describing the first seventeen subjects implanted at Emory University (15 (link)). Key inclusion criteria consisted of: 18 to 70 years-old with a diagnosis of major depressive disorder (confirmed with the Structured Clinical Interview for DSM-IV and by the study psychiatrists (PRP, SJG, PEH, ALC)); a current depressive episode of at least 12 months without significant response to at least 4 adequate antidepressant treatments (scoring 3 or higher on the Antidepressant Treatment History Form and verified through medical records); lifetime failure or intolerance of electroconvulsive therapy or inability to receive electroconvulsive therapy; average score ≥ 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17) averaged over the four weeks prior to surgery; Global Assessment of Functioning (GAF) of 50 or less; capacity to provide informed consent; and being able to relocate to the Atlanta area for 7 months (26 –29 ).
Key exclusion criteria were defined as: clinically significant medical or psychiatric comorbidity (including personality disorders as determined by a review of medical records, the Structured Clinical Interview-II, and clinical examination); active substance use disorder; active suicidal ideation with plan or intent, a suicide attempt within the past 6 months, or more than 2 suicide attempts within the past 2 years; pregnancy or planning to become pregnant during the study; or contraindication for DBS surgery or chronic stimulation.
The preoperative evaluation lasted a minimum of 4 weeks. Chronic stimulation was initiated 4 weeks following surgery. Outcome was assessed weekly for 24 weeks of active stimulation using the HDRS-17. Response to treatment was defined as at least a 50% decrease and remission as 7 points or less on the HDRS-17 at 24 weeks. For any missing timepoint the previous observation was carried forward to the next timepoint. Medication changes were not allowed during the preoperative evaluation phase or the initial 24 weeks of chronic DBS. All patients received cognitive behavioral therapy. Patients were aware that they were receiving active stimulation, but were not privy to the criteria for target identification, contact selection or dose increases. All procedures were carried out at Emory University.
