An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	Eli Lilly and Company
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00587639

Purpose

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.

Condition	Intervention
Depression	Device: rTMS Treatment

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Official Title:	An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Treatment: Active Comparator All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)	Device: rTMS Treatment Active rTMS treatment.

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 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.

Eligibility

Ages Eligible for Study:	13 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

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

Locations

United States, Illinois
Rush University	Recruiting
Chicago, Illinois, United States, 60612
Contact: Natalie Forburger 219-588-0688 nforburger@sbcglobal.net
Principal Investigator: Phillip G Janicak, MD
Sub-Investigator: Patricia M Meaden, PhD
Sub-Investigator: Sheila M Dowd, PhD
Sub-Investigator: Jeff Rado, MD
Sub-Investigator: Amer Smajkic, MD
Principal Investigator: Louis J Kraus, MD
Sub-Investigator: Hollie Sobel, PhD
Sub-Investigator: Louis F Fogg, PhD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Christopher A Wall, M.D. 507-284-3758 wall.chris@mayo.edu
Contact: Shirlene M Sampson, M.D. 507-284-3758 sampson.shirlene@mayo.edu
Principal Investigator: Christopher A Wall, M.D.
Principal Investigator: Shirlene M Sampson, M.D.
Sub-Investigator: Leslie A Sim, Ph.D.
Sub-Investigator: Brett A Koplin, M.D.
Sub-Investigator: Donald E McAlpine, M.D.
Sub-Investigator: Simon Kung, M.D.
United States, Texas
University of Texas Southwestern	Recruiting
Dallas, Texas, United States, 75390
Contact: Paul E Croarkin, DO 214-456-6888 paul.croarkin@childrens.com
Principal Investigator: Paul E Croarkin, DO
Principal Investigator: Mustafa M Husain, MD
Sub-Investigator: Frank A Kozel, MD
Sub-Investigator: Graham J Emslie, MD
Sub-Investigator: Peter L Stavinoha, PhD

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:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Mayo Clinic - Rochester ( Christopher A. Wall, M.D. )
Study ID Numbers:	07-000495
Study First Received:	December 21, 2007
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00587639 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

Adolescent
Depression
rTMS

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 27, 2009