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

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ClinicalTrials.gov Identifier: NCT02586688
Recruitment Status : Active, not recruiting
First Posted : October 26, 2015
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
Neuronetics

Brief 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).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS) Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS) Device: Open Label Active NeuroStar® TMS Not Applicable

Detailed 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Study Start Date : October 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Phase I TMS Active
Blinded Active TMS coil (Phase I). Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Device: Active NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®

Sham Comparator: Phase I TMS Sham
Blinded Sham TMS coil (Phase I) Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Device: Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)
Compare active NeuroStar® coil with sham NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®

Phase II Open Label Active TMS
Open label active TMS coil. Open label active NeuroStar® TMS.
Device: Open Label Active NeuroStar® TMS
Open label NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®

Phase III Long-Term Follow up TMS Active
Long term follow up with open label active TMS for retreatment as needed. Open label active NeuroStar® TMS.
Device: Open Label Active NeuroStar® TMS
Open label NeuroStar® coil.
Other Names:
  • TMS
  • NeuroStar®




Primary Outcome Measures :
  1. Hamilton Depression Rating Scale-24(HAMD24) total score change from baseline value. [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   12 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586688


Locations
United States, Alabama
Dothan Behavioral Medicine
Dothan, Alabama, United States, 36303
United States, California
UCLA
Los Angeles, California, United States, 90024
Stanford University
Palo Alto, California, United States, 94305
United States, Colorado
Rocky Mountain TMS
Grand Junction, Colorado, United States, 81501
United States, Florida
Florida Clinical Practice Association, Inc.
Gainesville, Florida, United States, 32606
Anchor Neuroscience
Pensacola, Florida, United States, 32502
United States, Indiana
Beacon Medical Group
South Bend, Indiana, United States, 46601
United States, Kentucky
Integrative Psychiatry
Louisville, Kentucky, United States, 40222
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21285
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
The Ohio State University
Columbus, Ohio, United States, 43210
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Neuronetics
Investigators
Principal Investigator: Paul Croarkin, MD Mayo Clinic
Study Director: Karen Heart Neuronetics

Publications of Results:
Responsible Party: Neuronetics
ClinicalTrials.gov Identifier: NCT02586688     History of Changes
Other Study ID Numbers: 44-02219-000
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Neuronetics:
child depression
depression
Transcranial Magnetic Stimulation
Adolescent Major Depressive Disorder
TMS
adolescent depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms