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An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression
This study is currently recruiting participants.
Study NCT00587639   Information provided by Mayo Clinic
First Received: December 21, 2007   Last Updated: July 20, 2009   History of Changes

December 21, 2007
July 20, 2009
May 2007
May 2009   (final data collection date for primary outcome measure)
CAVLT-2 The Children's Auditory Verbal Learning Test 2 is a neuropsychological test which takes approximately 25 minutes to complete. This test is designed for ages 6.6-17.11 years. It measures auditory verbal learning and memory. [ Time Frame: Pre-treatment and post treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00587639 on ClinicalTrials.gov Archive Site
CDRS-R - The Children's Depression Rating Scale, Revised is a validated, 17-item, clinician rating tool to assess severity of depression. Parents provide input into 14 of the items. This will be used to objectively assess level of depression. [ Time Frame: Pre-Treatment and throughout treatment ] [ Designated as safety issue: No ]
Same as current
 
An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression
An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression

The objective of this investigation is to examine the safety and feasibility of a series rTMS treatments (10 Hz; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 CRS Repetitive Transcranial Magnetic Stimulation (rTMS) system as adjuvant treatment for depression in adolescent subjects.

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 repetitive transcranial magnetic stimulation (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 L-DLPFC as adjuvant treatment for depression in adolescents.

 
Interventional
Other, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Depression
Device: rTMS Treatment
Active Comparator: All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
May 2009
May 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV diagnosis of unipolar major depression without psychosis.
  • Current or past history of lack of response to at least two adequate antidepressant trials (SSRI) operationally defined using the Antidepressant Treatment History Form (ATHF) (Sackeim 2001) 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 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
Both
13 Years to 18 Years
Yes
 
United States
 
NCT00587639
Christopher A. Wall, M.D., Mayo Clinic - Rochester
07-000495
Mayo Clinic
Eli Lilly and Company
Principal Investigator: Shirlene M. Sampson, M.D. Mayo Clinic
Principal Investigator: Christopher A. Wall, M.D. Mayo Clinic
Mayo Clinic
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP