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A Randomized Sham-Controlled Study of H-Coil Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Late-Life Depression

NCT01760681 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-01-04

No results posted yet for this study

Summary

The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison to a sham H-Coil rTMS in older patients with treatment-resistant major depressive disorder.Subjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS. The acute treatment phase will last four weeks. Treatment is administered daily, 5 days per week (i.e., 20 treatments). Depressive symptoms will be assessed using the HDRS-24. If subjects achieve the pre-defined primary outcome criteria of remission (HDRS-24 score \< 10 and 60% reduction in symptoms) they will continue with twice weekly treatment for two more weeks to ensure the durability of the remission. Subjects who do not achieve remission will exit the study after the acute treatment phase of four weeks. The blind will not be broken to subjects until the completion of the study

Conditions

Interventions

DEVICE

H- Coil DTMS

20 daily deep rTMS treatments

DEVICE

Sham

Sponsors & Collaborators

  • Shalvata Mental Health Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-01-31

Countries

  • Israel

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 NCT01760681 on ClinicalTrials.gov