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NCT00460902 Clinical Trial

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

Major Depression Clinical Trial

Official title:
Evaluation of the H-Coil Transcranial Magnetic Stimulation(TMS) Device- Augmentation for Drug Resistant Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00460902
Other study ID # 395/3.11.06(HMO)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received April 15, 2007
Last updated March 18, 2015
Start date April 2007
Est. completion date August 2009

Study information
Verified date March 2015
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Transcranial Magnetic Stimulation (TMS)

Locations
Country Name City State
Israel Beer Yaacov Medical Center Beer Yaacov
Israel Biological psychiatry unit, Psychiatric ward, Hadassah Medical organization Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Isserles M, Rosenberg O, Dannon P, Levkovitz Y, Kotler M, Deutsch F, Lerer B, Zangen A. Cognitive-emotional reactivation during deep transcranial magnetic stimulation over the prefrontal cortex of depressive patients affects antidepressant outcome. J Affect Disord. 2011 Feb;128(3):235-42. doi: 10.1016/j.jad.2010.06.038. Epub 2010 Jul 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HAMILTON RATING SCALE FOR DEPRESSION 24 items 4 weeks No
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