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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587639
First received: December 21, 2007
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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 Intervention
Depression
Device: rTMS Treatment

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 8
Study Start Date: May 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587639

Locations
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
Principal Investigator: Shirlene M. Sampson, M.D. Mayo Clinic
Principal Investigator: Christopher A. Wall, M.D. Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Christopher A. Wall, M.D., Mayo Clinic - Rochester
ClinicalTrials.gov Identifier: NCT00587639     History of Changes
Other Study ID Numbers: 07-000495
Study First Received: December 21, 2007
Results First Received: July 20, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Adolescent
Depression
rTMS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014