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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00587639
Recruitment Status : Completed
First Posted : January 7, 2008
Results First Posted : March 9, 2012
Last Update Posted : March 12, 2012
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Mayo Clinic

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Device: rTMS Treatment Not Applicable

Detailed Description:
High frequency rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) has been shown to have an antidepressant effect. Initial studies comparing electroconvulsive therapy (ECT) and rTMS suggest that rTMS has been as effective as ECT in treating non-psychotic depression. Given the high degree of ongoing dysfunction in depressed adolescents despite optimization of treatment with antidepressant medications, new concerns regarding suicidal thoughts and behaviors in adolescents treated with antidepressant medications, and the more interventional nature of ECT, the use of rTMS as adjuvant therapy may be of significant clinical benefit. Thus far, research using rTMS to treat depression in adolescents has been limited. The primary aim of this study is to examine the safety and feasibility of using 10 Hz rTMS applied to the left dorsolateral prefrontal cortex (L-DLPFC) as adjuvant treatment for depression in adolescents.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression
Study Start Date : May 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: rTMS Treatment
All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
 Device: rTMS Treatment
Active rTMS treatment.
Other Name: Neuronetics Model 2100 Therapy System


Outcome Measures
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Primary Outcome Measures :
  1. Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2) [ Time Frame: Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit) ]
    The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance.


Secondary Outcome Measures :
  1. Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R) [ Time Frame: At study visit 30 ]
    The Children's Depression Rating Scale, Revised (CDRS-R) is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. Scores range from 0 to 60, with the following scale: not depressed (<20), borderline depressive symptoms (20-29), mild depression (30-39), moderate depression (40-59), severe depression (>/=60).


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00587639


Locations
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United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Mayo Clinic
Eli Lilly and Company
Investigators
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Principal Investigator: Shirlene M. Sampson, M.D. Mayo Clinic
Principal Investigator: Christopher A. Wall, M.D. Mayo Clinic
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christopher A. Wall, M.D., Mayo Clinic - Rochester
ClinicalTrials.gov Identifier: NCT00587639    
Other Study ID Numbers: 07-000495
First Posted: January 7, 2008    Key Record Dates
Results First Posted: March 9, 2012
Last Update Posted: March 12, 2012
Last Verified: March 2012
Keywords provided by Mayo Clinic:
Adolescent
Depression
rTMS
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders