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

NCT02260765 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-08

No results posted yet for this study

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

Conditions

Interventions

DEVICE

dTMS

The Brainsway H-Coil TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep TMS by means of repetitive pulse trains at a determined frequency

Sponsors & Collaborators

  • Brainsway

    lead INDUSTRY

Principal Investigators

  • Alexander Alexander Bystritsky, MD, PhD · Healthcare Partners

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260765 on ClinicalTrials.gov