Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

Adolescent Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01170520
• Other study ID #: HT 4953
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: July 23, 2010
• Last updated: January 4, 2012
• Start date: August 2010

Study information

• Verified date: January 2012
• Source: Shalvata Mental Health Center
• Contact: Yuval Bloch, MD
• Phone: 972-506264628
• Email: yuvalbl[@]clalit.org.il; aviva100[@]bezeqint.net
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 18 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Depression
• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

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.

Locations

Country	Name	City	State
Israel	Shalvata Mental health Center	Hod Hasharon
Israel	Shalvata Mental Health Center	Hod Hasharon

Sponsors (1)

Lead Sponsor	Collaborator
Shalvata Mental Health Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Depression Rating Scale (CDRS) comparison before after therapy		4 weeks	Yes