NCT00587639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started May 2007

Typical duration for not_applicable depression

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

March 9, 2012

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

2.4 years

First QC Date

December 21, 2007

Results QC Date

July 20, 2011

Last Update Submit

March 8, 2012

Conditions

Depression

Keywords

AdolescentDepressionrTMS

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit)

Secondary Outcomes (1)

  • Mean Level of Depression at Visit 30, as Measured by the Children's Depression Rating Scale, Revised (CDRS-R)

    At study visit 30

Study Arms (1)

rTMS Treatment

EXPERIMENTAL

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

Device: rTMS Treatment

Interventions

rTMS TreatmentDEVICE

Active rTMS treatment.

Also known as: Neuronetics Model 2100 Therapy System
rTMS Treatment

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rush University

Chicago, Illinois, 60612, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

Related Publications (2)

  • 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.

    PMID: 21951987RESULT

  • 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.

    PMID: 31634515DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

Limitations of the study include its open design, and small number of total participants.

Results Point of Contact

Title
Dr. Christopher Wall
Organization
Mayo Clinic
wall.chris@mayo.edu
5072843352

Study Officials

  • Shirlene M. Sampson, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Christopher A. Wall, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

May 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

March 12, 2012

Results First Posted

March 9, 2012

Record last verified: 2012-03

Locations

US(3)