Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device in the Treatment of Bipolar Depression

This study has been completed.

Sponsor:

Information provided by:

Shalvata Mental Health Center

ClinicalTrials.gov Identifier:

NCT00444938

First received: March 7, 2007

Last updated: February 4, 2009

Last verified: March 2007

History of Changes

Purpose

This study is evaluating the potential antidepressive effect of a 4 week treatment protocol using the H-coil deep TMS device in bipolar depression.

Condition	Intervention	Phase
Bipolar Depression	Device: H1 -coil TMS device	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the H-Coil (TMS) Device - Safety and Feasibility in Bipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Study Start Date:	June 2006
Study Completion Date:	March 2008

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of bipolar depression

Exclusion Criteria:

No other axis I disorder
Risk factors for convulsions

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444938

Locations

Israel
Shalvata MHC
Hod Hasharon, Israel

Sponsors and Collaborators

Shalvata Mental Health Center

Investigators

Principal Investigator:

Eiran V Harel, MD

Shalvata MHC

More Information

No publications provided by Shalvata Mental Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harel EV, Zangen A, Roth Y, Reti I, Braw Y, Levkovitz Y. H-coil repetitive transcranial magnetic stimulation for the treatment of bipolar depression: an add-on, safety and feasibility study. World J Biol Psychiatry. 2011 Mar;12(2):119-26. Epub 2010 Sep 21.

ClinicalTrials.gov Identifier:	NCT00444938 History of Changes
Other Study ID Numbers:	SH-50506
Study First Received:	March 7, 2007
Last Updated:	February 4, 2009
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 18, 2013

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