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Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170520
Recruitment Status : Unknown
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was:  Recruiting
First Posted : July 27, 2010
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Shalvata Mental Health Center

Brief Summary:

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 or disease Intervention/treatment Phase
Adolescent Depression Device: repetitive transcranial Stimulation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2010
Estimated Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Child Depression Rating Scale (CDRS) comparison before after therapy [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01170520

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Contact: Yuval Bloch, MD 972-506264628;

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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   
Sponsors and Collaborators
Shalvata Mental Health Center

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Responsible Party: Shalvata Mental Health Center Identifier: NCT01170520     History of Changes
Other Study ID Numbers: HT 4953
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

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

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