Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
Primary Purpose
Adolescent Depression
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
repetitive transcranial Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Depression focused on measuring adolescent resistant depression, repetitive transcranial magnetic stimulation, treatment of resistant adolescent depression
Eligibility 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
Sites / Locations
- Shalvata Mental health Center
- Shalvata Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rTMS
Arm Description
Outcomes
Primary Outcome Measures
Child Depression Rating Scale (CDRS) comparison before after therapy
Secondary Outcome Measures
Full Information
NCT ID
NCT01170520
First Posted
July 23, 2010
Last Updated
January 4, 2012
Sponsor
Shalvata Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT01170520
Brief Title
Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
Official Title
The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Depression
Keywords
adolescent resistant depression, repetitive transcranial magnetic stimulation, treatment of resistant adolescent depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
repetitive transcranial Stimulation
Intervention Description
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 Measure Information:
Title
Child Depression Rating Scale (CDRS) comparison before after therapy
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Bloch, MD
Phone
972-506264628
Email
yuvalbl@clalit.org.il; aviva100@bezeqint.net
Facility Information:
Facility Name
Shalvata Mental health Center
City
Hod Hasharon
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, MD
Phone
972-97478644
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, MD
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuval Bloch, MD
Phone
972-9-7478510
Email
yuvalbl@clalit.org.il
12. IPD Sharing Statement
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Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
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