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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
rTMS Treatment
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Adolescent, Depression, rTMS

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rush University
  • Mayo Clinic
  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rTMS Treatment

Arm Description

All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)

Outcomes

Primary Outcome Measures

Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)
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)
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).

Full Information

First Posted
December 21, 2007
Last Updated
March 8, 2012
Sponsor
Mayo Clinic
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00587639
Brief Title
An Evaluation of Safety and Feasibility Using Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression
Official Title
An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Adolescent, Depression, rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS Treatment
Arm Type
Experimental
Arm Description
All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
Intervention Type
Device
Intervention Name(s)
rTMS Treatment
Other Intervention Name(s)
Neuronetics Model 2100 Therapy System
Intervention Description
Active rTMS treatment.
Primary Outcome Measure Information:
Title
Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2)
Description
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.
Time Frame
Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)
Secondary Outcome Measure Information:
Title
Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)
Description
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).
Time Frame
At study visit 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirlene M. Sampson, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher A. Wall, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21951987
Citation
Wall CA, Croarkin PE, Sim LA, Husain MM, Janicak PG, Kozel FA, Emslie GJ, Dowd SM, Sampson SM. Adjunctive use of repetitive transcranial magnetic stimulation in depressed adolescents: a prospective, open pilot study. J Clin Psychiatry. 2011 Sep;72(9):1263-9. doi: 10.4088/JCP.11m07003.
Results Reference
result
PubMed Identifier
31634515
Citation
Sonmez AI, Kucuker MU, Lewis CP, Kolla BP, Doruk Camsari D, Vande Voort JL, Schak KM, Kung S, Croarkin PE. Improvement in hypersomnia with high frequency repetitive transcranial magnetic stimulation in depressed adolescents: Preliminary evidence from an open-label study. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Mar 8;97:109763. doi: 10.1016/j.pnpbp.2019.109763. Epub 2019 Oct 18.
Results Reference
derived
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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