Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

NCT ID: NCT01170520

Last Updated: 2012-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adolescent Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rTMS

Group Type EXPERIMENTAL

repetitive transcranial Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shalvata Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shalvata Mental health Center

Hod HaSharon, , Israel

Site Status NOT_YET_RECRUITING

Shalvata Mental Health Center

Hod HaSharon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yuval Bloch, MD

Role: CONTACT

Facility Contacts

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Yuval Bloch, MD

Role: primary

972-97478644

Yuval Bloch, MD

Role: primary

972-9-7478510

Other Identifiers

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HT 4953

Identifier Type: -

Identifier Source: org_study_id

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