An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression

Completed · Not applicable

Conditions studied: Depression

In brief

The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz \[Hz\]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects.

Key facts

Study ID

NCT00587639

Run by

Mayo Clinic

People needed

8

Starts

2007-05-01

Expected to finish

2009-10-01

Last updated by the study team

2012-03-12

Who can join

Age: 13 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of unipolar major depression without psychosis.
• Current or past history of lack of response to at least two adequate antidepressant trials selective serotonin re-uptake inhibitors (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF)
• Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or higher at baseline
• At least six weeks of ongoing SSRI therapy at a stable dose.
• SSRI Medications will include:
• Citalopram (Celexa, Cipramil, Emocal, Sepram)
• Escitalopram oxalate (Lexapro, Cipralex, Esertia)
• Fluoxetine (Prozac, Fontex, Seromex, Seronil, Sarafem, Fluctin (EUR))
• Fluvoxamine maleate (Luvox, Faverin)
• Paroxetine (Paxil, Seroxat, Aropax, Deroxat)
• Sertraline (Zoloft, Lustral, Serlain)
• Age 13-18 years.
• Outpatient, inpatient, or partial hospitalization patients.
• Capable of providing informed assent/consent (in addition to parent/guardian consent).

You may not qualify if…

• Current Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, mental retardation, pervasive developmental disorder, somatoform disorder, dissociative disorder, posttraumatic stress disorder, obsessive-compulsive disorder, eating disorders, antecedents of autism, and all personality disorders.
• Active substance dependence (except nicotine) in the past 12 months.
• Subjects with a history of head trauma, unprovoked seizure history, seizure disorder, or family history of treatment resistant epilepsy.
• Suspected pregnancy or pregnancy as confirmed by a urine pregnancy test at screening.
• History of failure to respond to ECT.
• Metal in the head (except in the mouth), implanted medication pump, cardiac pacemaker.
• Prior brain surgery.
• Risk for increased intracranial pressure such as brain tumor.
• Unable to obtain motor threshold in the subject or motor threshold too high, such that 120% MT cannot be obtained (i.e. >84% of device output).
• Significant change or increase in antidepressant medications within the last six weeks.
• Change in psychiatrist, psychologist, or therapist within the last four weeks.
• Suicide attempt within the past three months.
• Any suicide attempt or suicidal intent during the study will terminate involvement in this study.
• Subjects currently on stimulant, antipsychotic, atypical antidepressant or tricyclic antidepressant medications.
• Unstable medical or neurological conditions that may include hematological, infectious (such as Human immunodeficiency virus [HIV] positive patients) metabolic, or cardiovascular conditions that may preclude safe participation in trial.
• Subjects undergoing anticoagulant, immune suppressive and 1 or chemotherapy, or those who received any of these therapies </=3 months before enrollment in the study
• Subjects with intra-cardiac lines

Where it is running

• Rush University — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Texas Southwestern — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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