Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
This study is currently recruiting participants.
Verified January 2012 by Shalvata Mental Health Center
Sponsor:
Shalvata Mental Health Center
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
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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
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 Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on October 17, 2012
