Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Major Depressive Disorder Clinical Trial

Official title:

A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02586688
• Other study ID #: 44-02219-000
• Status: Active, not recruiting
• Phase: N/A
• First received: October 23, 2015
• Last updated: January 31, 2018
• Start date: October 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Neuronetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).

Description:

To evaluate the antidepressant effects of daily, active TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder, single or recurrent episode (Phase I).

Secondary:

To evaluate the acute and long term safety of TMS treatment in adolescent MDD subjects.

To evaluate the durability of benefit of TMS treatment over the course of 6 months in subjects who received clinical benefit from acute treatment course(s) (Phase III).

To evaluate the benefit of daily, active, open-label TMS in Phase I subjects who did not receive protocol-defined clinical benefit; as new acute treatment (sham to active) or as extended treatment course (blinded active to open label active) (Phase II).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 21 Years

Eligibility

Inclusion Criteria:

• Primary diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features

• Duration of current episode of depression =4 weeks and =3 years

• Clinical Global Impression - Severity of Illness = 4

• Resistance to antidepressant treatment in a discrete illness episode

• HAMD24 Item 1 = 2 and total score = 20

• Subjects able to commit to protocol visit schedule

• At the end of the baseline visit, subject must have a HAMD24 score of = 18 and change in score may not be = 25% decrease from that seen at the screening visit

Exclusion Criteria:

• Prior TMS, vagus nerve stimulation (VNS), or electroconvulsive therapy (ECT)

• Contraindication to TMS

• Cardiac pacemakers, implanted medication pumps, intracardiac lines

• History of neurological disorder

• Unstable medical conditions

• Any psychiatric disorder, which in the judgement of the Investigator may hinder the subject in completing the procedures required by the study protocol.

• Significant acute suicide risk

• Inability to locate and quantify a motor threshold

• If sexually active female, not on an accepted method of birth control.

• Diagnoses of the following conditions (current unless otherwise stated):

• Depression secondary to a general medical condition, or substance induced:

• Seasonal pattern of depression as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

• Any psychotic disorder (lifetime), including history of schizophrenia, schizoaffective disorder, other psychosis, psychotic features in this or previous episodes, amnestic disorder,

• Intellectually disabled,

• Substance dependence or abuse within the past year (except nicotine or caffeine),

• Bipolar disorder,

• Obsessive compulsive disorder (lifetime),

• Post-traumatic stress disorder (lifetime),

• Eating disorder (lifetime).

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
• Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
• Open Label Active NeuroStar® TMS
Open label NeuroStar® coil.

Locations

Country	Name	City	State
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati College of Medicine	Cincinnati	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	Dothan Behavioral Medicine	Dothan	Alabama
United States	Florida Clinical Practice Association, Inc.	Gainesville	Florida
United States	Rocky Mountain TMS	Grand Junction	Colorado
United States	UCLA	Los Angeles	California
United States	Integrative Psychiatry	Louisville	Kentucky
United States	Stanford University	Palo Alto	California
United States	Anchor Neuroscience	Pensacola	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Beacon Medical Group	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Neuronetics

Country where clinical trial is conducted

United States, 

References & Publications (3)

Carpenter LL, Janicak PG, Aaronson ST, Boyadjis T, Brock DG, Cook IA, Dunner DL, Lanocha K, Solvason HB, Demitrack MA. Transcranial magnetic stimulation (TMS) for major depression: a multisite, naturalistic, observational study of acute treatment outcomes — View Citation

O'Reardon JP, Solvason HB, Janicak PG, Sampson S, Isenberg KE, Nahas Z, McDonald WM, Avery D, Fitzgerald PB, Loo C, Demitrack MA, George MS, Sackeim HA. Efficacy and safety of transcranial magnetic stimulation in the acute treatment of major depression: a — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value.		6 weeks