Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

January 4, 2012 updated by: Shalvata Mental Health Center

The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hod Hasharon, Israel
        • Not yet recruiting
        • Shalvata Mental health Center
        • Principal Investigator:
          • Yuval Bloch, MD
        • Contact:
          • Yuval Bloch, MD
          • Phone Number: 972-97478644
      • Hod Hasharon, Israel
        • Recruiting
        • Shalvata Mental health Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child Depression Rating Scale (CDRS) comparison before after therapy
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shalvata Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Estimate)

January 5, 2012

Last Update Submitted That Met QC Criteria

January 4, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HT 4953

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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