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Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression

NCT01566591 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-04

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of H1-Coil deep brain rTMS in subjects with bipolar depression, taking mood stabilizers and previously unsuccessfully treated with antidepressant medications.

Conditions

Interventions

DEVICE

Deep TMS Treatment

24 TMS treatments over 6 weeks .

DEVICE

Sham Treatment

24 TMS treatments over 6 weeks

Sponsors & Collaborators

  • Brainsway

    lead INDUSTRY

Principal Investigators

  • Yechiel Levkovitz, MD · Shalvata Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States
  • Canada
  • Germany
  • 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 NCT01566591 on ClinicalTrials.gov