Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedJanuary 5, 2012
January 1, 2012
3.1 years
July 23, 2010
January 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child Depression Rating Scale (CDRS) comparison before after therapy
4 weeks
Study Arms (1)
rTMS
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shalvata Mental health Center
Hod HaSharon, Israel
Shalvata Mental Health Center
Hod HaSharon, Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2010
First Posted
July 27, 2010
Study Start
August 1, 2010
Primary Completion
September 1, 2013
Last Updated
January 5, 2012
Record last verified: 2012-01