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

Depression Clinical Trial

Official title:

An Evaluation of Safety and Feasibility Using rTMS in Adolescents With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00587639
• Other study ID #: 07-000495
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: March 8, 2012
• Start date: May 2007
• Est. completion date: October 2009

Study information

• Verified date: March 2012
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• rTMS Treatment
Active rTMS treatment.

Locations

Country	Name	City	State
United States	Rush University	Chicago	Illinois
United States	University of Texas Southwestern	Dallas	Texas
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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).	At study visit 30	No

External Links

•   Mayo Clinic Clinical Trials