Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Shalvata Mental Health Center.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 01, 2014