Ignite Creation Date:
2024-05-06 @ 12:24 AM
Last Modification Date:
2024-10-26 @ 10:49 AM
Study NCT ID:
NCT01566591
Status:
UNKNOWN
Last Update Posted:
2021-02-04
First Post:
2012-03-27
Brief Title:
Safety and Efficacy Study of Deep Transcranial Magnetic Stimulation in Bipolar Depression
Sponsor:
Brainsway
Organization:
Brainsway
Study Overview
Official Title:
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
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None