Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents

Shalvata Mental Health Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Adolescent Depression

Treatments: Device: repetitive transcranial Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01170520

HT 4953

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 15 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

rTMS

Experimental group

Treatment:

Device: repetitive transcranial Stimulation