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Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

This study is currently recruiting participants.
Verified January 2012 by Shalvata Mental Health Center
Sponsor:
Information provided by (Responsible Party):
Shalvata Mental Health Center
ClinicalTrials.gov Identifier:
NCT01170520
First received: July 23, 2010
Last updated: January 4, 2012
Last verified: January 2012
History of Changes
  Purpose

The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.

A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.


Condition Intervention Phase
Adolescent Depression
 Device: repetitive transcranial Stimulation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Shalvata Mental Health Center:

Primary Outcome Measures:
  • Child Depression Rating Scale (CDRS) comparison before after therapy [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: August 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS Device: repetitive transcranial Stimulation
rTMS using the figure of 8 magstim for 4 weeks or 20 work days, using 100% threshold to the LDPFC 42 trains per day 4 sec pretrain inter train interval of 30 sec.

  Eligibility

Ages Eligible for Study:   15 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 15-18 years old
  • Right hand dominant
  • Suffering from major depression
  • CDRS > 60
  • At least 3 months of current depressive episode
  • Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy
  • No contraindication for rtms (safety questionnaire)
  • No change in pharmacotherapy in the last month

Exclusion Criteria:

  • Schizophrenia or psychotic symptoms
  • Hypertension
  • Epilepsy
  • History of major head trauma
  • Metal implements in the head
  • History of neurosurgery
  • History of severe head migraine
  • History of hearing loss or sp cochlear transplantation
  • Pregnancy
  • Current drug abuse
  • Unstable medical condition
  • History of manic episode
  • Current treatment with lithium or tricyclic or tetracyclic antidepressants
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170520

Contacts
Contact: Yuval Bloch, MD 972-506264628 yuvalbl@clalit.org.il; aviva100@bezeqint.net

Locations
Israel
Shalvata Mental health Center Not yet recruiting
Hod Hasharon, Israel
Contact: Yuval Bloch, MD     972-97478644        
Principal Investigator: Yuval Bloch, MD            
Shalvata Mental Health Center Recruiting
Hod Hasharon, Israel
Contact: Yuval Bloch, MD     972-9-7478510     yuvalbl@clalit.org.il    
Sponsors and Collaborators
Shalvata Mental Health Center
  More Information

No publications provided

Responsible Party: Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT01170520     History of Changes
Other Study ID Numbers: HT 4953
Study First Received: July 23, 2010
Last Updated: January 4, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Shalvata Mental Health Center:
adolescent resistant depression
repetitive transcranial magnetic stimulation
treatment of resistant adolescent depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013