Evaluation of the Deep TMS H-Coil in the Treatment of Major Depression- Augmentation of Antidepressant Medication

Phase 1

Completed

• Conditions: Major Depression
• Interventions: Device: Transcranial Magnetic Stimulation (TMS)

• Registration Number: NCT00460902
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Evaluation of the novel deep TMS H-Coil design as an augmentation measure in the treatment of medication resistant major depression. Stimulation is administered with and without cognitive-emotional provocation.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-15
• Study First Submitted QC: 2007-04-15
• Study First Posted: 2007-04-17
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients diagnosed as suffering from treatment resistant major depression
• Right laterality

Exclusion Criteria

• other major axis I diagnosis
• severe axis II diagnosis
• risk factors to convulsions
• history of drug abuse in the past year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep TMS stimulation	Transcranial Magnetic Stimulation (TMS)	-
DTMS with positive cognitive-emotional provocation	Transcranial Magnetic Stimulation (TMS)	-
DTMS with negative cognitive-emotional provocation	Transcranial Magnetic Stimulation (TMS)	-

Primary Outcome Measures

Name	Time	Method
HAMILTON RATING SCALE FOR DEPRESSION 24 items	4 weeks

Trial Locations

Locations (2)

Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization; 🇮🇱 Jerusalem, Israel

Beer Yaacov Medical Center; 🇮🇱 Beer Yaacov, Israel