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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

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

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

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

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

yuvalbl@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

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