NCT01566591

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

A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction With Mood Stabilizers in Subjects With Bipolar Depression

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Brainsway · Industry
• Sex: All
• Age: 22 Years – 68 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi center, randomized, double blind study 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. The study is designed for a period of 8 weeks of which up to 3 weeks subjects will be tapered down from their medications and treated for 5 weeks. Two follow up visits will be performed at week 6 and 8 after the last TMS treatment. Mood and mental status will be closely monitored with standard psychological scales and assessments

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DEVICE	Deep TMS Treatment	24 TMS treatments over 6 weeks .
DEVICE	Sham Treatment	24 TMS treatments over 6 weeks

Timeline

• Start date: 2012-05-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2012-03-29
• Last updated: 2021-02-04

Locations

13 sites across 4 countries: United States, Canada, Germany, Israel