Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual

Depression Clinical Trial

Official title: Post Marketing Study to Evaluate the Resource Utilization of Patients Suffering From Resistant Depression Treated With Deep TMS in Comparison to Treatment as Usual

Status Withdrawn

Clinical Trial Summary

The aim of the study is to evaluate the efficacy of the Deep TMS compare to TAU and the different in resource utilization of treating depression with Deep TMS compare to the TAU.

The current study is a prospective semi-naturalistic, randomized study in which depressed patient who failed to respond to at least one medication or could not tolerate at least two antidepressants and are seeking for alternative treatment will be offered to join an open label study. The study designed as double arm study of which patient will have 50% chance to be randomized to one of the study groups.

The study includes two arms. The dTMS study group will be treated according to the cleared FDA treatment protocol of 4 weeks of daily treatment following by additional 12 weeks of biweekly treatment and overall of 44 treatments. The Treatment As Usual arm will be treated by their primary care physician / psychiatrist according to the usual treatment recommend to the patient clinical status

Clinical Trial Description

many patients do not respond to antidepressant or could not tolerate the adverse events. Hence, many patients are looking for medical alternatives. Those alternatives include psychotherapy, ECT, and TMS. The direct cost of those treatments is relatively high compare to antidepressants. However, the indirect costs including hospitalizations, physician visit, ER visits, pharmacy claims, labs and adverse events management may increase the overall costs and burden of illness for the health system. This study aims to evaluate the efficacy of the Deep TMS compare to TAU and the different in indirect costs of treating depression with Deep TMS compare to the TAU.

The current study is a prospective semi-naturalistic, randomized study in which depressed patient who failed to respond to at least one medication or couldn't tolerate at least two antidepressants and are seeking for alternative treatment will be offered to join an open label study. Patients eligible for the study will be asked to sign the informed consent. Than patients will be randomized to either Deep TMS treatment or TAU. The Deep TMS study group will receive the TMS treatment protocol as was cleared by the FDA. The TAU study group will be treated by their primary care physician / psychiatrist according to the usual treatment recommend to the patient's clinical status. Patient may continue its current treatment (with / without medications) or switch to a new treatment. However, treatment should be stable for at least 30 days prior to baseline visit except of Fluoxetine in which 45 days are required. Patients will be followed at 4 weeks and 6 month following baseline visit. The deep TMS treatment includes 4 weeks of acute daily treatment (20 treatments) following by 12 weeks of biweekly maintenance treatment. The purpose of the study is to explore the efficacy of the Deep TMS treatment compare to TAU and to investigate the differences in resource utilization between the study groups. The study population will be based on the FDA cleared patient population for the Deep TMS treatment. Safety will be assessed by monitoring of adverse events Other assessment scales will be used during the course of the study. Efficacy will be assessed using the Hamilton Depression Rating Score (HDRS), the self-reported questionnaires the QIDS-SR and the PHQ-9. Quality of life will be assessed by the Q-Les-Q questionnaire. Disability will be assessed by the Sheehan Disability Scale. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

• NCT number: NCT02260765
• Study type: Interventional
• Source: Brainsway
• Status: Withdrawn
• Phase: N/A
• Start date: October 2014
• Completion date: September 2020